D D O T S, I n c.
System Update History
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06/12/2017
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http://www.ddots.com/navigators/Updater%2006122017.pdf
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Prestudy Calculator
Staff Regulatory Access
Arm Notes
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05/30/2017
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http://www.ddots.com/navigators/Updater%2005292017.pdf
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Prestudy Consent Form Log
Patient Mailing Labels
Adverse Event Title Changes
Billing Compliance
Protocol Components Hide and Show
Hide IRB Meeting Dates
DDOTS Protocol Library |
05/15/2017
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http://www.ddots.com/navigators/Updater%2005152017.pdf
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Research Team Expiring License
Calendar Start Date Pre-Study |
05/01/2017
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http://www.ddots.com/navigators/Updater%2005012017.pdf
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Continuing Review Report
IDEA Edit Inventory
IDEA Select Dispense Date |
04/17/2017
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http://www.ddots.com/navigators/Updater%2004172017.pdf
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Direct Cost Note
@EnrollingHospital Macro
Cannot Remove Protocol, Attachments: Popup as to why
Email Fields to include for Expiring studies
Milestone Collection: Billable
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04/03/2017
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http://www.ddots.com/navigators/Updater%2004032017.pdf
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Consent Types |
03/20/2017
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http://www.ddots.com/navigators/Updater%2003202017.pdf
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Continuing Review Email Content |
03/06/2017
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http://www.ddots.com/navigators/Updater%2003062017.pdf
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Birthday notifications
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02/20/2017
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http://www.ddots.com/navigators/Updater%2002202017.pdf
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Target Accrual Email
Filter Research Team
Expiring Study Notification Email Note
Deviation Log Email Content Control
"Email All" Research Team |
02/06/2017
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http://www.ddots.com/navigators/Updater%2002062017.pdf
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Target Accrual Email
Prestudy & Patient Demographics now synced
"My Events" from Main Menu
15 Day Expire Study Option |
01/23/2017
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http://www.ddots.com/navigators/Updater%2001232017.pdf
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Search Engine
Protocol Arm Notes
Prestudy Screen Date
Master Schedule New Columns
Invoice Generator New Filter
Receivables Report New Filters and Columns
On\Off Study Report New Column |
12/26/2016
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http://www.ddots.com/navigators/Updater%2012262016.pdf
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User Defined Fields
Master Schedule Financials
Lock "SOC\Rsrch" on patient check-off calendars
Blank "Completed" date
On\Off Study Report with Departments
Include Rainbow Page notes on Invoice
Prestudy Add\Edit Manual Events is now a Staff Access right
Consent "Notes" now show up on patient\study page
New "Patient Status Report"
Direct Payable Documents carry over to RFPs
Enable "Event Quantity" to allow staff to select how many labs were done. |
12/12/2016
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http://www.ddots.com/navigators/Updater%2012122016.pdf
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New Institutions IRB
My Events Filter
Investigator & Coordinator Reports has Summary
Pre-IRB Report Updated
Financials for Monitor Visits can be Flat Charge or via Hourly Rate
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11/28/2016
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http://www.ddots.com/navigators/Updater%2011282016.pdf
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Searchable User Defined Fields
Prestudy Outcome Reasons
Search Invoice Number
CPT Code entry via Rainbow page |
11/14/2016
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http://www.ddots.com/navigators/Updater%2011142016.pdf
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My Events Configuration
Bypass the "GO" button
Patient Calendar Filters
Record Prestudy Patient Notes via Report
Prestudy Icon on Navigation Bar
Mimic Pharmacy Package Ordering Pharmacy to Pharmacy |
10/31/2016
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http://www.ddots.com/navigators/Updater%2010312016.pdf
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Regluatory Submissions Report
Patient Forms Available
Ignoring Prestudy Events per Outcome
Changing IRB of Record for All Components
New Staff License Report Filter
Reset Event Ordering on Rainbow Page
Columns to Include when Updating Patient Calendars from Rainbow Page
Master Schedule Report, New Column: Checkoff Delay in Days
IDEA, Add Manual Dispense Event |
10/17/2016
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http://www.ddots.com/navigators/Updater%2010172016.pdf
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Review History Log
Billing Compliance Grid & CPT Codes
Pre-IRB (ORC Recordings) Report
IDEA Update Drug\Placebo Options |
10/03/2016
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http://www.ddots.com/navigators/Updater%2010032016.pdf
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Billing Compliance
Modifier Codes
Milestone Collection Regulatory
Prestudy Arm Assignment
Financial Parameters Regulatory
Request for Payment (RFP) email
IDEA Patient Arm DARF |
09/20/2016
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http://www.ddots.com/navigators/Updater%2009192016.pdf
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Email Patient\Protocol
Link Hospital Calendar Events to Protocol. |
08/22/2016
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http://www.ddots.com/navigators/Updater%2008222016.pdf
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Social Security Number
Medical Record Number
Prestudy Workup
Patient Calendar Filter
Payment Generator Report
Invoice Register Report
Direct Cost Account
Headers for Segment Months
Documents for Direct Costs
System setting to Enable\Disable "Original Coordinator" |
07/25/2016
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http://www.ddots.com/navigators/Updater%2007252016.pdf
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Financial Guide
IRB of Record Report
Rainbow Page Formatting Font
Billing Compliance Consent Date
Billing Compliance Email Fields
Patient Search by Alias Name
Edit Rainbow Page Headers
IRBANA Meeting Documents for Review by Status
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07/11/2016
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http://www.ddots.com/navigators/Updater%2007112016.pdf
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Review Months
Analyze Financials
Non-Agenda Notation
Protocol Sponsor Report
On Off Study Report
Patient Milestone Report
Lock ORC Notes
RFP Documents
Pre-Study Workup
Time Task Recorder
Update DAR Lots
Drug Transport Location |
06/27/2016
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http://www.ddots.com/navigators/Updater%2006272016.pdf
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Account Line Items Report
Pre-IRB/ORC Recordings Report
Filter Milestones by Patient or event
Internal Cost Report
On\Off Study Report
View my Events
Add\Edit Manual Events
Transport Multiple Drugs |
06/13/2016
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http://www.ddots.com/navigators/Updater%2006132016.pdf
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Consent
Credit Summary Report
Internal Cost Report
Internal Mail Next\Previous buttons
ORC\Pre-IRB Page Redesign
Protocol Summary Module
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05/31/2016
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http://www.ddots.com/navigators/Updater%2005312016.pdf
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Deviation Report
Monitor Visit Billable
Patient Calendar Completion
Master Schedule Report Exclude hot links
Add DAR Memo to Undo events
Recuse Voting Staff in IRBANA |
05/14/2016
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http://www.ddots.com/navigators/Updater%2005162016.pdf
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Staff License
Staff Navigation
Macros |
04/30/2016
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http://www.ddots.com/navigators/Updater%2004302016.pdf
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Calendar
Split Checks
Status Report Sorting
Allocation Page Filter
Staff Affiliations
Research Team Alerts |
04/11/2016
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http://www.ddots.com/navigators/Updater%2004112016.pdf
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Filter My Events
Billing Compliance Grid Filter
Peek-thru Research Team Resigned Staff
IRBANA New Document Flag Removal after reveiw |
03/26/2016
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http://www.ddots.com/navigators/Updater%2003262016.pdf
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RFP, Deviation Log
Research Team Sort
Payables Checkbox
NCT Number
Pre-Study Patient
Event Invoices
Cost Center Masked
Follow-Up Sheet
Billing Compliance Grid Filter
Archive Licenses Research Team
Non-Provided Drug Schedule
Consent Form Log on Dispense |
03/12/2016
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http://www.ddots.com/navigators/Updater%2003122016.pdf
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default billing compliance
projected receivables report
rainbow page header |
02/20/2016
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http://www.ddots.com/navigators/Updater%2002202016.pdf
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Lock Review Logs
Invoice Generator
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02/06/2016
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http://www.ddots.com/navigators/Updater%2002062016.pdf
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Regulatory Event Locking
Off Treatment Reason Required
Off Study Reason Required
Adverse Event Grade Description
Rename Patient Protocol: Arm Notes
Archive Staff
Patient Audit History now has Email
Edit Staff Notifications
Invoice Generator
Staff License Report
Flag Calendar Completion Events for Email
Quick Links between: Pharmacy & Protocol
Dispense X days into Future
Meeting Documents for Review: Re-order Documents |
01/16/2016
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http://www.ddots.com/navigators/Updater%2001162016.pdf
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Email Send Via (Internal\External) default
Staff Groups for Emailing
View My Events Printing
New Acuity Ranking Report
New Internal Cost Report
Copy Prohibited Drugs to Arms
Dispense History on Patient DAR
New Meeting Reviewer Summary Report |
11/28/2015
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CREDIT:
1. The Invoice Register Report now includes "Cost Center" as a Column to Include.
2. The Report for Protocol Archive Locations is now interactive. Archiving and adding Locations can be done directly within the report.
3. Request for Payment Service Providers now allows for "Service Provider ID" to be included in the Print feature. For this to function, the Service Provider needs to have that field entered in their File Ops profile via "Edit Service Provider".
4. The Protocols by Department Report now allows for the IRB ID to be a Column to Include.
5. The Protocol Review Expire Date now has links for various date default loading.
IDEA:
1. See CREDIT: 1, 2, 3, 4
IRBANA:
1. See CREDIT: 1, 2, 3, 4, 5
BIOSPEC:
1. See CREDIT: 2, 3, 4, 5
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Cost Center
Protocol Archive
Review Expire Date |
10/31/2015
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CREDIT:
1. The ORC Recording Report title, is now pulled from the System setting for the "Name" of the ORC Recording Title. Some sites changed it to "Pre-IRB", and now the Report will reflect that name as well.
2. Financial Payments can now be sorted by Check Number by clicking on the Source link at the top of the column. Also, Statements can now be ordered by Check Number.
3. There has always been an Email Notification system for study reviews that are "Expiring". Now there is a parallel system for continuing studies "due for review". They are both managed via File Ops > IRB > Edit IRB Environment.
4. Staff who get notified of Patient Off Treatment or Off Study via internal system mail will now also get notifications via Email.
5. The Main Menu can now have an Emergency Message display the first time each user logs on, for a set date range. The Message is entered via FileOps > System > Edit Emergency Message.
6. In the File Ops > System > Staff Notifications module, some notices can now be tagged for Internal Mail or External Mail notification.
IDEA:
1. See CREDIT: 2, 4, 5, 6
IRBANA:
1. See CREDIT: 1, 2, 3, 5
2. Meeting Documents for Review can now be Bulk Downloaded per Submission.
BIOSPEC:
1. See CREDIT: 1, 2, 3, 4, 5, 6
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10/17/2015
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CREDIT:
1. The Patient Study Registration Date has been available for Enable for many years. Now, via File Ops > System > System Variable Defaults > (the date can be Required).
2. The content of the Billing Compliance Email can now be managed via File Ops > System > System Variable Defaults > Fields to Include on Billing Compliance Email
3. There are new releases of the "CREDIT Introductory Guide" documents. When inside of the system, click on HELP, then DDOTS On-line Help Documents. They are Alpha sorted, so scroll down to "CREDIT....."
4. The link on the Main Menu "View My Events" now has an option in the "Configuration" tab to display events in Calendar Format vs. Listing.
5. There is already a system setting for "Allow Adding to Existing Invoices". Now,there is another for "Lock invoices", which will, after the day of the invoice, not allow it to be deleted or saved.
6. The Protocol Current Status Report now has a Column to Include: Last Revision Activity. It is pulled from the IRB of Record, IRB: Revision Log.
7. When any IRB Log is Edited, the name and date of staff who made the initial entry is displayed in the upper section of the popup window.
IDEA:
1. See CREDIT: 1, 4, 5
IRBANA:
1. See CREDIT: 4, 5, 6, 7
BIOSPEC:
1. See CREDIT: 1, 4, 5
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10/03/2015
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CREDIT:
1. The Financial Protocol Specific report can now be filtered by Cost Centers.
2. There is a new NCI Crediting file now inside of the CREDIT system. This file should have many of the missing Credits that the NCI updated.
3. There is a new field available in the File Ops > System > System Variable Defaults > Patient\Study > Show Pregnancy Status.
4. When editing a Document in the IRB Library, there is now a check box to tag the document as "Patient" side available.
5. If the Protocol IRB Expire Date is enabled, when the user loads the date, CREDIT looks at the last review date and does some math to determine if the user has loaded a date that is not in violation of the 12 months. If there is a violation, it will not allow the user to save until the Expire Date is fixed to be within the 12 months.
IDEA:
1. See CREDIT: 1, 3, 4, 5
2. There is a new Staff Access that allows a given user to ONLY see a "Quick Load" link on the Main Menu. The link takes the user to the Quick Load File Ops page where they can create a new patient entry, and capture all the hospital, doctor, and protocol.
IRBANA:
1. See CREDIT: 1, 5
BIOSPEC:
1. See CREDIT: 1, 3, 4, 5
2. The Invoice now includes the item Label and Project ID.
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09/19/2015
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CREDIT
1. There are two new features on the Financial Invoice Register. On the left side, the report can be Filtered by words in the Memo and\or Notation in the Invoice data. On the right side, for Columns to include, if the boxes are checked for Memo and\or Notation, there is another check box to "Allow Edit". If checked, the output page will have a pencil next to these displays that is linked to open up the cell for editing.
2. The Financial Invoice Print output now includes the Prestudy Patient ID for Screen Failures.
3. The Main Menu > IRB Forms module now allows for bulk document download.
4. The Financial Request for Payments (RFP) now includes the ability to have the Patient Protocol ID included in the document. This is managed in File Ops > System > System Variable Defaults > "Request For Payment Patient Information Inclusion" > (new radio button to select this option).
5. Filter Feature for Morphology field on PreStudy work up page for institutions that have the Morphology in Prestudy Enabled.
6. Changed CCOP Physician to NCORP Physician on Staff Profile Page.
7. Adds Country of Birth to Patient & Prestudy. (Must be Enabled in System)
IDEA:
1. See CREDIT: 1, 4, 6, 7
IRBANA:
1. See CREDIT: 1, 3, 4, 6
BIOSPEC:
1. See CREDIT: 1, 4, 5, 6, 7
2. The system can now create Manifests, Packing Slips, Invoices, log Payments, and report for Invoice Aging.
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08/15/2015
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NCORP Notice: The NCI just released a new Crediting Database. All sites have been upgraded with the new data within CREDIT. If you were unable to locate the correct Credit settings for a given study in the past, please re-try now. This impacts Aug 2015 and newer accruals only. 2014 Credit settings are not updated.
CREDIT:
1. There is now an option to have Morphology as a selection in the Pre-Study Workup page. To enable this, there is a System setting to Enable Morphology. That enables it on the Patient Protocol Page. Next to the Enable setting is a new check box to allow it to show up on Pre-study Workup pages as well. Further, when enabled, and the Prestudy patient is Activated, the Morphology setting is carried over to the Patient Protocol Page.
2. In Financials, there is a new System Setting: "Ability to Create Related Payables from the Direct Costs Page". When this is Enabled, if a Direct Cost "Pass Through" amount is entered, it automatically will create a "Direct Payable" ready to be included in a Request for Payment (RFP).
3. Billing Compliance Grid Codes can now be added to the system. File Ops > Add\Edit Billing Compliance Grid Codes.
IDEA:
1. See CREDIT: 2, 3
IRBANA:
1. See CREDIT: 2
BIOSPEC:
1. See CREDIT: 1, 2, 3
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08/01/2015
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NCORP & CCOP:
The recent changes to the NCI crediting procedures have resulted in a much more complex and flexible system.
We've recently launched the first phase of our integration which allows credits to be assigned in the new NCI crediting format.
To do so, access the Add/Edit Activity area via the "Rainbow Page". From there, you will specify the Credit Type (CC or RX), the Credit Values (including both Standard Performance, or "SP", and High-Accruing Performance, or "HP") just as before.
However, the big change comes with regards to the Funding Criteria, which is now required to successfully "link" the crediting events to their NCI counterparts. There are two ways to do this. First, you can use the "Study Selector" dropdown box. If the study is not new and the NCI has released the crediting information to us, you should be able to quickly scroll through that box, locate the credit (and its funding type) and select it. This is the preferred (and easier) manner by which you can link the credits.
If the credits are NOT located in the Study Selector, you will need to manually "drill-down" through the Funding Criteria to select the options that define the credit.
Over the next year, staff should begin updating their studies so that their credits reflect the correct values and the correct "linkage" to the NCI credits. Within the next month, DDOTS will be releasing updated NCORP reports (formerly the CCOP reports) that will ultimately be used to verify 2015-2016 submissions using the linkages that were assigned during this process.
CREDIT
1. There is a new System setting that allows for the Default Ordering of IRB Logs. Then, as staff go into a specific protocol and IRB Log, they can change the order per their preference. The System will remember the staff, protocol, log, and sort order.
IDEA:
1. See CREDIT:
IRBANA:
1. See CREDIT: 1
2. There are 2 new Macros available for Agenda and Letters:
@IRBInitialApprovalDate and @IRBInitialApprovalWordDate
This would be the date a new study has the first Action of "Approved." This is the date the study has met all contingencies, not the first time it is reviewed.
BIOSPEC:
1. See CREDIT: 1
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07/18/2015
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CREDIT
1. There are 2 new Macros available for Document Merging:
@IRBPICompany
@IRBCoordinatorCompany
2. Within a Staff Profile, multiple licenses can now be added at one time.
IDEA:
1. See CREDIT: 1, 2
IRBANA:
1. See CREDIT: 1, 2
BIOSPEC:
1. See CREDIT: 1, 2
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07/04/2015
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NOTICE NCI Reporting Credits: The DDOTS Reports and Crediting System is still a few weeks away. While we are in transition, we will be Disabling the Credit Reports in the system. The Links will be there, but with a strike-out, and the not clickable. These will be restored when the transition has been completed. We expect this to be done by the end of July.
CREDIT
1. The "Unanticipated Problems" logs are now capable of being included in Financial Milestone Collection (Invoice creation).
2. There is now a System setting that allows Showing or Hiding Financial Documents in the IRB Documents Library. By default, it is "Enabled". Main Menu > File Ops > System > System Variable Defaults > "Show Financial Documents in IRB Document Library".
3. There is a new Macro for Regulatory Forms merging: @ResearchTeam. The macro will pull the entire current Research team and list them in stacked order including their "Contact Type" (PI, Coordinator, Data Manager, etc....)
4. The Protocol Rainbow Page "Billing Compliance Grid" can now be sort ordered.
5. There is a new System setting that allows for Locking Comments in the Patient Audit Logs. File Ops > System > System Variable Defaults > "Lock Comments on Patient Audit Log" and "Lock Corrective Action on Patient Audit Log". If they are Enabled, the system will allow users the ability to Add to those note fields, but not Edit the content.
IDEA:
1. See CREDIT: 1, 2, 3, 5
2. DARFs can now be filtered by Package Size.
IRBANA:
1. See CREDIT: 1, 2, 4
BIOSPEC:
1. See CREDIT: 1, 2, 3, 4, 5
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06/20/2015
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CREDIT
1. There are new "Filters" available in the module: Main Menu > IRB Forms (this could be renamed locally at sites). The Mini-Menu allows for Add\Edit\Delete key words to be used as Filters when a Document is uploaded into the system. This way, a single document uploaded can have multiple filters attached. So when users want "Initial Study Forms", as an example, they get all documents within that folder that qualify.
This solves the problem of having to create dozens of Folders, then uploading common documents over and over again into each Folder. Instead, make one Folder "IRB Forms" and upload all document there giving each on a set of Filter Words.
So if there is a document "Campus Layout", you might want that in every single Document uploaded. When the user asks for "Annual Review Form", they get the Campus Layout document too.
3. Financial Requests for Payment can now have the content "Sort Ordered" such that they are ordered by entry date or date of event.
IDEA:
1. See CREDIT: 1, 2
IRBANA:
1. See CREDIT: 1, 2
2. The IRB Documents for Review Comments box for reviewer entry shows up when the box for Completed is checked. Once saved, that box can be Edited by Un-checking the Completed box and saving. That action tells IRBANA that there is yet more to be done. Re-checking the box again opens up the Comments box displaying the previously entered comments for Editing.
BIOSPEC:
1. See CREDIT: 1, 2
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06/06/2015
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CREDIT
1. The Staff License Report now has a Filter to Include Licenses with No Expire Date.
2. There is a new Macro available for Invoice Printing: @ProtocolSummary
IDEA:
1. See CREDIT: 1, 2
IRBANA:
1. See CREDIT: 1, 2
2. IRBANA Staff Notice: There is a new "Introductory Guide IRBANA Submitters" document in the Help module. Click on HELP on the top bar of IRBANA, then "DDOTS On-Line Documents". Scroll down the alpha sorted documents to locate the NEW Guide.
BIOSPEC:
1. See CREDIT: 1, 2
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05/23/2015
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NOTICE: As of June 1, 2015 the price for Protocol building by DDOTS will be $35. Updates to Protocols will continue to be free for the life of the study.
MEMBER REQUEST: Does anyone know of an affordable, easy to use EDC system (other than spread sheets)?
CREDIT
1. The Patient Protocol Medical Record Number (Hospital Number) can now have a default Prefix. As an example, if all of the numbers must begin with "M", that can now be put into File Ops > System > System Variable Defaults > Pre-Study > Medical Record Number must begin with:
2. The Protocol Current Status report now has Radio Buttons for "Current Status" and "Historical Status". When "Current" is selected, the Date Range is hidden (and the system uses Today for both Start and Stop dates). When "Historical" is selected, the Date Range system is shown.
3. The Protocol Data page has various staff showing as a "Peek-thru" from the Research Team page. The Ordering of those staff is by Contact Type. Now, via File Ops > System > System Variable Defaults > Protocol Data > Protocol Data Page Research Staff Peek-Throughs the Order of Contact Types listed there will be the Order of Staff Contact types listed on the Protocol Data Page.
4. The Report for Staff Licenses now allows for "Bulk Download" for creating a Zip file of selected uploaded licenses.
IDEA:
1. See CREDIT: 1, 2, 3, 4
IRBANA:
1. See CREDIT: 2, 3, 4
2. In the IRB Logs, and in Edit mode for an event, if the IRB Meeting has already passed, and Attendance was taken and recorded in the system, the Voting Listing will be filtered to match those in attendance at the meeting.
BIOSPEC:
1. See CREDIT: 1, 2, 3, 4
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05/09/2015
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CREDIT:
1. For sites that have the "Birthday Notification" setting Enabled in File Operations, there is a new field that allows for Notification in xx advanced days of the birth day. The setting is Protocol specific. On the Protocol Data page, if Enabled, there is a box to list the birthdays for patients that staff need email notification for "8,12,18,21" as an example.
2. There is a new IRB Revision Log, Revision ID option that can "Standardize" submissions to the IRB. Currently, the "Revision ID" is a free text field, which remains the default. However, if that field needs to be a selectable drop-down box, that is now an option. It requires 2 elements to be set. First one is in File Ops > IRB > Add Revision ID. Once all of the various "Standardized" IDs are loaded, the system needs to be Enabled. File Ops > System > System Variable Defaults > IRB "Revision ID" Uses "Revision ID Dropdown Select Box" needs to be Enabled. Going forward, whatever the Submitter selects from the Standardized Listing, will be captured as the IRB Revision Log ID for that event.
3. There are a series of new fields that can be Enabled via the System settings:
Risk Determination Level
Pediatric Risk Determination
Device Determination
There are also data merge Macros to suppor them:
@RiskDeterminationLevel
@PediatricRiskDetermination
@DeviceDetermination
4. The "Staffing Assignments" Peek-Thru on the Protocol Data Page is now sort ordered by the System setting that indicates which Types of Staff should be in the Peek-Thru. So, If the PI is not at the top of the list, and it is desired to do that: File Ops > System > System Variable Defaults > Protocol Data > Protocol Data Page Research Staff Peek-Throughs.
5. Unanticipated Problems can now be Enabled in the IRB Follow-up Sheets. File Ops > IRB > IRB Meeting Environment > Optional Pages to Include on IRB Follow-Up Sheets
IDEA:
1. See CREDIT: 1, 2, 3, 4
IRBANA:
1. See CREDIT: 2, 3, 4
2. In the IRB Logs, there has always been a link to "Documents" for each event. Those links allowed for Merging the event with a Document Template. Now, if the user has IRB Reviewer Access in their staff profile, there is a new set of links: Letter of Action. When clicked, there is a popup that lists the Letters from the Letter Generator. The listing is filtered to match the specific event the letter is for. Clicking on the specific letter link will create the merged letter for that event.
BIOSPEC:
1. See CREDIT: 1, 2, 3, 4
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04/25/2015
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CREDIT:
1. If a date of death is entered in the Patient File Cab, that date is now carried over into Prestudy.
2. There are many new IRB Related Macros available:
@IRBMeetingDate (this meeting date)
@IRBMeetingDate(X) (this meeting date + X days)
@IRBMeetingWordDate (this meeting date in the form of "September 9, 2015")
@IRBMeetingWordDate(X) (this meeting date + X days in the form of "September 9, 2015")
@IRBNextMeetingDate (the next scheduled meeting date)
@IRBNextMeetingDate(X) (the next scheduled meeting date + X days)
@IRBNextMeetingWordDate (the next scheduled meeting date in the form of "September 9, 2015")
@IRBNextMeetingWordDate(X) (the next scheduled meeting date + X days in the form of "September 9, 2015")
@IRBNextReviewMeetingDate (the next scheduled review for THIS study -- 11 months from now, for example)
@IRBNextReviewMeetingDate(X) (the next scheduled review for THIS study -- 11 months from now, for example -- + X days)
@IRBNextReviewMeetingWordDate (the next scheduled review for THIS study -- 11 months from now, for example -- in the form of "September 9, 2015")
@IRBNextReviewMeetingWordDate(X) (the next scheduled review for THIS study -- 11 months from now, for example -- + X days in the form of "September 9, 2015")
3. The Protocol Current Status Report now has 2 new Radio Buttons "Current Status Only" (which uses TODAY for Start and Stop), vs. "Historic Status Uses Dates Below" (for a Date Range of history). There is also a small image "NEW" that shows up when a new major element of a page has changed. This should alert staff to take a closer look at the new element added to the page. The "New" button is showing in this report and will be hidden after 1 month.
4. In the Financials Module, when collecting milestones to create an Invoice, staff are allowed to select an "Account Line Item" for each service listed in the Invoice. Now those selections can be "Defaulted" by the selection being made via the Rainbow Development Page. When Editing any Event, the "Account Line Item" dropdown box is available for pre-determining what should be selected during the Invoice Action.
IDEA:
1. See CREDIT: 1, 2, 3, 4
IRBANA:
1. See CREDIT: 2, 3
2. The list of Reviewers in the IRB Logs, now has the Primary\Secondary\Vote hidden for standard IRBANA users. The logon user must have a new staff profile set in order to view and assign those columns. In the staff profile: "IRB Reviewer" must be checked in order to assign reviewers. THIS IS A NEW CHANGE and may require staff profile updating if staff currently do not have the IRB Reviewer capability checked.
BIOSPEC:
1. See CREDIT: 1, 2, 3, 4
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04/11/2015
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CREDIT:
1. There is a new Staff Access right: "IRB Delete Documents". By default, logon staff who could Upload documents can also Delete documents. If you have staff that should not have this authority, you can edit their staff profile, and uncheck the box that allows for the delete action.
2. There is a new option in the Research Team page. "Also add an entry for these Hospitals:". There is a listing of institutions in the system with a checkbox next to each. This way, when a staff is added to the specific protocol, the staff can also be added to the other institutions at the same time.
IDEA:
1. See CREDIT: 1, 2
IRBANA:
1. See CREDIT: 1, 2
BIOSPEC:
1. See CREDIT: 1, 2
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03/21/2015
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CREDIT:
1. There is now an IRB Adverse Event Description "Mouse-Over" for the "Grade". The description of the Grade must first be added into File Ops > System > System Variable Defaults > IRB Activities > Adverse Event "Grade" Mouse-Over Description.
2. If there is an Outstanding Issue in a Staff Profile, and that staff is part of any Research Team, when the License link is clicked on the Research Team page, the Outstanding Issue is also displayed.
3. The Invoice Footer can now also be displayed on the bottom of Statements. To enable this feature, Click the button "Invoice Footer" on the Invoices Page. At the bottom of the edit box is a new Check Box for inclusion of the Footer on Statements.
4. An Invoice Payor can now be set to the Study PI. For this to happen, the PI must be loaded into the Research Team as the PI. Once there, a new link may appear on the ADD Payor in the upper left of the Invoice Page. If there are other Payors available, they will appear in the dropdown select list, and by default, selected to be "Added". If the PI is not yet set up in the Payor Listing, another link will appear "Add PI". That link will take the PI Staff information and populate the Payor data table such that the PI can then become an Invoice Payor.
5. There is a new Text box inside of each Invoice. The function is simply allow the user to make comments about the history of the Invoice. The text information does not print on the invoice.
IDEA:
1. See CREDIT: 2, 3, 4, 5
IRBANA:
1. See CREDIT: 2, 3, 4, 5
2. The IRB Letter Generator now allows for selecting "Favorites" from the Letter Listings. Listed letters are those containing the "@" symbol indicating that a Macro is being used as a part of the letter. There is also a new link at the top of the page to Show vs. Hide the entire Letter Listing.
3. There is a feature in the system that allows for an "IRB Meeting Submission Cutoff" period. By default it is disabled, allowing submissions to be made right up and into the date of the meeting. If this feature is Enabled, IRB Submission Meeting Date Selections will be limited based on the number of days before the meeting per the Cut-off Days setting. Staff with Administrator settings in the Staff Profile automatically override this feature, as they can make submissions at any time. This feature can be found via: Main Menu > File Ops > IRB > Edit IRB Meeting Environment Defaults > "Meeting Agenda Event Cut-Off Days Activated".
BIOSPEC:
1. See CREDIT: 2, 3, 4, 5
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03/07/2015
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DDOTS has just released the beginning of product branding. Color changes to CREDIT, IDEA, IRBANA, and BIOSPEC have been implemented. Over the next few updates additional color changes to pages will happen. The functionality of all systems remains the same through the branding color changes.
CREDIT:
1. There is a new Pre-Study option in the module for Adding a Pre-study Patient and the workup all at one time. This is in addition to the Bulk Load Screener where multiple entries can be made at one time. The new link, found in the Mini-Menu in Pre-Study Patients allows for adding the Patient and the Workup all on one easy-to-use page.
IDEA:
1. See CREDIT:
IRBANA:
1. See CREDIT:
BIOSPEC:
1. See CREDIT:
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02/21/2015
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CREDIT:
1. The File Ops > Edit Staff & Assignments now filters out Resigned Staff. There is a link to click to reload the select box to Include Resigned Staff. Additionally, after saving an entry, there is now a link to "Return to Edit Select Page".
IDEA:
1. See CREDIT: 1
IRBANA:
1. See CREDIT: 1
2. The IRB Letter Generator now lists all of the existing Letters on the right side of the Selection Page. The letters are linked to take the user directly to that letter bypassing the selection settings on the left side of the page.
BIOSPEC:
1. See CREDIT: 1
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02/14/2015
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CREDIT:
1. The IRB Logs that have documents uploaded are now sorted by Document Title. Therefore, giving documents a number can result in the user defining in which order documents will be displayed "01-"..."12-"... etc.
2. The IRB Meeting Activity Recorder now includes Unanticipated Problems.
3. The Protocol Current Status Report now allows for a new column "Months Between Reviews".
4. The Invoice Aging Report now allows for Sub-Totaling per Cost Center.
5. There is a new Macro for merging via the Patient Protocol page, DOCUMENTS Print link: @PrestudyConsentDate.
6. Financial Direct Costs that have been Invoiced cannot be Edited. However, there is a new "Pencil" edit for editing the Note for the Direct Cost.
7. The Invoice Page now has the "Time-Task Recorder" button in the top left corner.
8. If the System "Reason for Outcome" is Enabled for Pre-study, the Bulk Screening Pages now will have that option as well as the main "Workup" page for a patient.
IDEA:
1. See CREDIT: 1, 4, 6, 7
2. When Destroying all agents (perhaps due to study closure), there is now an ALL link to check all of the boxes for the destruction, and a MIMIC link to cascade the Reason Why to all inventory events as well.
3. On the Patient Protocol Page, where the Drug Inventory is listed, if the listing contains Expired Drug, it is now so noted.
IRBANA:
1. See CREDIT: 1, 2, 3, 4, 6, 7
2. When in the IRB Logs (Revisions, Reviews, etc...) if the Uploaded Attached Documents are set to "New Document for Review", the word "NewDoc" will appear next to the document view in the Logs. This keeps staff from having to go into the IRB Document Library to see if a document is set to "New" or not.
3. New Documents for Review Ordering now displays the documents within a submission are now sorted by Document Title.
BIOSPEC:
1. See CREDIT: 1, 2, 3, 4, 5, 6, 7
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01/17/2015
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CREDIT:
1. The NCI CCOP\NCORP Reports now pull Credits in from Prestudy Patient Calendars.
2. The File Operations module now has multiple “Anchor” links to navigate the page.
3. The File Ops > Staff > Edit Staff > Show Existing File module has been updated. If the "Logon Capable" blue link at the top is clicked, the page will reload only with Logon Capable staff.
4. The Current Status Report now allows for Multiple Department Selection.
5. Staff License Notifications and the Institution Certification notifications historically have been sent out using the 30/60/90 days for just the staff. However, now each element has it's own notification lead time. So Staff can have 30 days while Certifications can be set to 60 or 90 days.
IDEA:
1. See CREDIT: 2, 3, 4, 5
2. When inside of a study in the Pharmacy, instead of the user selecting "Patient\Protocol list" from the Mini-Menu , then clicking on the GO button to get to the Search Engine, the Search Engine now is always displayed in the lower right of the toolbox and is available for searching.
Further, even if the search engine is used to find another study, the Mini-Menu remains in the old study in case access to it is still wanted... or the Search Engine was just used to see if another study is listed. This way, the original study is still available for use via the Mini-Menu if the Search Results links are not clicked on to select a different study.
IRBANA:
1. See CREDIT: 2, 3, 4, 5
BIOSPEC:
1. See CREDIT: 2, 3, 4, 5
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12/20/2014
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NOTICE to NCI CCOPs: If you need your Logon and Main Menu Pages Institution Name changed due to NCORP status, please reply to this email with the new name.
CREDIT:
1. The Protocol NCT Number title can now be changed via File Ope > System > System Variable Defaults > Protocol > Protocol NCT Number Title.
2. The Protocol Financial "Contract Binder Number" can now be re-titled in the same way as noted above.
3. The Financial Cash Receipts Journal now allows searching via Check # or Invoice #.
4. On the Patient Protocol Page, there has always been an option to Enable "Accrual Association" which lists all of the Sponsors as selectable for the patient accrual. Now, however, that long sponsor listing can be rolled back to just Selected Sponsors. In File Ops > Protocol > Edit Sponsor... the sponsor page has a new Checkbox on it to Include the Sponsor in that Listing on the Patient Protocol page for selection. All of this is dependant on the System Settings. File Ops > System > System Defaults > Show "Membership" Association for Accruals on Patient\Protocol Page. That needs to be Enabled and can also be made Required (if needed).
Also, when editing a Sponsor, the "Show Existing File" option now shows which Sponsors are "Active" and included in the Accrual Association previously mentioned. It is also noted that the Sponsor Abbreviation is now linked to allow immediate editing of the clicked sponsor.
5. The Main Menu "Hospital Calendar" can now be renamed via: File Ops > System > System Variable Defaults > Main Menu > Text for Hospital Calendar.
6. The Master Schedule Report can now be filtered per Billing Compliance Codes.
7. The NCI CCOP\NCORP Report for Crediting now includes and Credits checked off in Prestudy Patient Calendars.
IDEA:
1. See CREDIT: 1, 2, 3, 4, 5, 6
2. There is a new set of IDEA Introductory Guides available at: https://www.ddotscredit.com/DDOTSHelp/DocumentsPage01.cfm
IRBANA:
1. See CREDIT: 1, 2, 3, 5
2. There is a new Macro for IRB Letters: @AgendaName. It will pull the name of the Agenda that is attached to the Meeting Date from which the letters are generated.
BIOSPEC:
1. See CREDIT: 1, 2, 3, 4, 5, 6
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12/06/2014
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CREDIT:
1. The Protocol Research Team page now allows for uploading documents to support the staff listed. The documents are not staff specific, rather they are "team" specific. To enable this feature, in the File Ops > System > System Default Values > Show Document Upload In Research Teams.
2. The Patient Calendar has had 2 Views: User View & Patient View. There is now a 3rd option: Blank. When selected, only staff notes made on the calendar are displayed. This facilitates creating a “Pill Calendar” without other events showing. It also allows for staff to simply print the blank calendar and write notes on it for the patient.
IDEA:
1. See CREDIT: 1, 2
IRBANA:
1. See CREDIT: 1
2. There is a new setting for Submitters. You can turn OFF their view of Reviewers on the IRB Log Submissions. It is a new Staff Access right: IRB: Reviewers. Setting to Read only will show submitters the listing of Reviewers. Write check box allows for assigning Reviewers to a submission.
BIOSPEC:
1. See CREDIT: 1, 2
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11/01/2014
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CREDIT:
1. Financial Statements can now be filtered by Invoice Number.
2. Prestudy Screening Arms now have a "Calendar Start" date for users to begin the screening calendar.
3. When applying a payment in financials, the Allocation Page can now be filtered for Check Number or Patient ID.
4. For many years there has been an "all" link on the patient checkoff calendar that triggers all events for a given date to be checked with one click. Now, next to that link is a new "echo date". This allows for setting the date of the first event for the day, then clicking the "echo date" link to have that date copied into all events for that day.
5. For NCI CCOPs and NCORPs, the Rainbow page now allows for copying Credits from one Arm to another.
6. The Financial Invoice Register report now breaks out "Overhead" percentage on Patient Milestones for Invoices that had that feature turned on.
IDEA:
1. See CREDIT: 4, 5
IRBANA:
1. See CREDIT: 1, 2, 3
BIOSPEC:
1. See CREDIT: 1, 2, 3, 4, 6
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08/23/2014
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CREDIT:
1. The IRB Module Logs now hides the Add Button when clicked. This prevents double entry.
2. There is now a feature in the Financials module that allows staff to Add Invoice Items to an existing Invoice. Basically, Collect Milestones, then with the popup window, select the Invoice you would like to add Milestones to.
3. There is now a new set of Staff Access rights to allow staff to see (or not) IRB Document "Comments" and "Downloaded By". By default, the Access Rights are checked.
4. When a patient is Consented from one Arm of a study to a New Arm of the same study, there is a check-box to "Create New Consent Form Log Entry" for this Arm.
5. The Prestudy Report now allows for new Columns: Patient Address, Patient SS Number (if that is Enabled).
IDEA:
1.. See CREDIT items: 1, 2, 3, 4
IRBANA:
1. See CREDIT items: 1, 2, 3
BIOSPEC:
1. See CREDIT items: 1, 2, 3, 4, 5
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08/09/2014
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CREDIT:
1. There is a new\additional Request for Payment System. It allows for assigning which staff will be "Credited\Paid" for any given event. This can be the "Investigator, Coordinator, Patient, or Other". This feature must be enabled per Institution if it is to be used.
To Enable this feature, File Ops > System > System Variable Defaults > Protocol-Arms > Use "Event Performed By" Functionality in These Hospitals (Select Institutions for Activation).
When this has been saved, all studies for those institutions will have the feature available. On the Rainbow Page (Arm Schema Design) Add\Edit Labs (as an example). For the system to work, it is expected that there will be an Invoice Amount set for the Sponsor to pay. Once that is done, under the Lab Name, the Staff Selection for "Pay Out" is made, and the amount of dollars is set.
The result of this is the Patient Check-Off Calendar will now display the name of the Pay-out Staff. If the staff is the Coordinator for the Patient, yet someone else performed the task, the stafffing can be changed right there and then. Once checked Completed and Saved, the event is available in the Financial Module for the study.
The Request for Payment (RFP) module now has 2 options, one the Traditional RFP, and the new Payout RFP. A radio button allows for selection.
Once the RFP for Pay-out is "Collected" the events from the Patient Calendar appear. However, there are rules for what comes intot the Collected Popup:
a. If it is pay to patient, it automatically comes up.
b. Only if funds have been logged IN (check received from sponsor) and applied to the event, will it come up.
c. If Partial payment was made by the sponsor, the event will come up as Partal Pay-out at the percent rate of what the sponsor paid. So, if the sponsor owes $100, and the Investigator gets $40, the sponsor only pays $50, the Payout shown in the RFP will be $40 for the Investigator.
Finally, there is a place to enter the actual check number and check date for the Pay-out once Accounting has cut the check.
2. There is a new feature that allows for "Pre-Study" Arms to be built for a protocol. Starting next week, all DDOTS New Study build that have "Screening" will come with a Pre-Study Screening Arm. This means when a patient is Worked Up in Prestudy, and the Protocol is selected, IF there is a Pre-Study Arm, it will build a calendar for check-offs right there in Pre-Study. Further, these events can be Financially Involved and get collected as Milestones.
For this feature to work, when Adding and Arm, there is now a checkbox for "Pre-Study Screening Arm Only". Check that box and when a new patient is screened for the study, that Arm will be available. And, that Arm will NOT be available for general attachment for Activated Patients.
IDEA:
1. See CREDIT items: 1, 2
IRBANA:
1. See CREDIT items:
BIOSPEC:
1. See CREDIT items: 1, 2
GENERAL HELP:
1. There are new "CREDIT Introductory Guides" available via the HELP Icon. When the Help Window pops up, click on "DDOTS On-Line Help Documents", then scroll down to the "CREDIT" word (alpha listing) to see the "Guides". Review of the Guides will explain many new features that have been constructed in the system over the past couple of years. This is an excellent training guide for new staff.
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07/26/2014
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CREDIT:
1. The First Review Report can now be exported to Excel.
2. On the Patient Protocol Page, in the top right there are 2 new links "Print" and "Word". They link to the Docments Module where an unlimited number of forms, letters, etc., can be created. When a Document is Selected, it will be Merged with the Patient Information. If Print is clicked, the output goes into a popup window for printing. If Word is clicked, the document is exported to Word for final editing and saving.
3. There are 4 new Patient Protocol Macros: @PDRWorkName (Primary Doctor Work), @ProtocolSummary, @InvestigatorSuffix, @InvestigatorTitle (where Investigator is the Registering person for the patient on the study).
4. When adding a Manual Event to a patient calendar, the user can now attach a "Staff Task" and assign default hours and minutes to the task. The Rainbow Page already allows for this feature, and now the Manual Events module has it as well.
IDEA:
1. See CREDIT items: 1, 2, 3, 4
IRBANA:
1. See CREDIT items: 1
2. The New Documents for Review Report can now be sort ordered for the type of submission.
BIOSPEC:
1. See CREDIT items: 1, 2, 3, 4
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07/12/2014
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CREDIT:
1. The protocol Search Engine now allows for searching for studies via the PI.
IDEA:
1. See CREDIT items: 1
IRBANA:
1. See CREDIT items: 1
BIOSPEC:
1. See CREDIT items: 1
GENERAL HELP:
1. Attention CCOPs: The NCI has changed their Upload File Format. You may need to upload your file, correct entries on the NCI site, and change some accruals that happened prior to March 2014 for this final reporting period. Going forward into next year, this will not be a problem.
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06/21/2014
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CREDIT:
1. When a target accrual is hit, the system can now stop accruals (not allow the study to show up for selecting in Dropdown Boxes). For this feature to function, there is a System setting to allow for a CAP to be enabled once a target accrual has been reached. IF this CAP is enabled, when reached, CREDIT would remove and ACTIVATE buttons from Pre-Study Patient workups and Patient File Cabinet for this protocol until the site disables the CAP feature in File Ops.
2. There is a new feature that populates the "Current Accruals" box with the patient count. Prior to this, the Current Accrual Count was entered by hand by the user. This Manual Entry process is still the default. However, in the System settings, there is a new option "Automatic Accrual Calculation. When this is Enabled, the system automatically counts the accruals every time the Protocol Data Page is opened.
3. There is a new column in the Master Scheduile Report: Research vs. SOC.
4. The Master Schedule Date Range now allows for connecting to the Event Check-off Date in patient calendars. That date is automatically captured when staff check off events. So, if an event happened June 3, and was checked off June 5, we can set the date range to June 5 and see what was historically checked off.
5. The Patient Document Upload Module now allows for creating a Patient Calendar Event for each upload. As an example, perhaps the document being uploaded is a Query request. On the upload screen, an Activity "Data Query" could be selected and that Manual Event would be sent to the Patient Calendar for staff to mark as "Completed" when it occurs.
6. There is a new Financial Hourly Rate feature. When on the Financial Parameters page (Acrual page) there is a place for setting the Hourly Rate for work beyond the contract. When staff Tasks are associated with the study, they become collectable Milestones. That rate is a "Flat Rate" and applies to all staff. There is now a new checkbox next to the rate that tells the system to look up the staff Salary Rate in the Staff Profile. So, if a Data Manager has a Salary Rate of $30 per hour, and a RN has a Salary Rate of $45 per hour, those values will be used for Tasks performed by the different staff when Milestones are collected.
7. The Maximium Number of Months between Reviews can now be set in File Ops > IRB > IRB Meeting Environment Defaults > (choose IRB) > Maximium Month Review Duration. The Default is 12, but can be changed as needed. The impact of the setting allows for every study managed by the selected IRB to have that Maximium Months as the top range.
8. There are several new Macros available for the Patient Deviation Print that pull directly from the Patient Protocol Page for Staffing:
@InvestigatorTitle @InvestigatorFirst @InvestigatorMiddle @InvestigatorLast @InvestigatorSuffix
@CoordinatorTitle @CoordinatorFirst @CoordinatorMiddle @CoordinatorLast @CoordinatorSuffix
@DataManagerTitle @DataManagerFirst @DataManagerMiddle @DataManagerLast @DataManagerSuffix
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7, 8
IRBANA:
1. See CREDIT items: 7
BIOSPEC:
1. See CREDIT items: 1, 2, 3, 4, 5, 7, 8
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06/07/2014
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CREDIT:
1. There is a new System setting that can prompt staff to select a Pre-Study Outcome Reason if specific Outcomes are selected on the patient workup. Main Menu > File Operations > System > System Default Values > "Force Prestudy Outcome Reason When Outcome Is:"
2. The Pre-Study Patient Report now allows for gettiong the report in "Recording" mode. This mode allows for updating the Outcome of patient workups directly within the report. As an example, perhaps there were 25 Bulk Screenings that were set to "In Progress", and 20 of them need to be set to "No Response". Pull the report in Recording Mode and easily change those 2 Outcomes.
IDEA:
1. See CREDIT items:
IRBANA:
1. See CREDIT items:
BIOSPEC:
1. See CREDIT items: 1, 2
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05/24/2014
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CREDIT:
1. Rules for inserting the PI on an Invoice:
- IF there is only 1 PI in the Team, whether or not the PI is resigned, we *could* still use that PI.
- IF there is (are) resigned PI(s), but 1 not resigned, we could use that one.
- IF there are multiple resigned PIs, and no active PIs, we could use a resigned PI with the most recent resign date.
2. When adding a staff to the Research Team page, if the selected staff has Expired License(s) there is a notice flag on the page.
3. When an IRB Revision Log entry is made, and the "Also Record For" feature is being used, any email sent out will be sent for each of the studies selected.
IDEA:
1. See CREDIT items: 2, 3
IRBANA:
1. See CREDIT items: 2, 3
BIOSPEC:
1. See CREDIT items: 2, 3
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05/10/2014
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CREDIT:
1. There is a System setting that can be Enabled for filtering Billing Compliance Emails to Exclude "Non-Billable" events from the patient calendars.
2. The Protocol NCT Number can now be set to Required via the System Settings.
3. There is a new feature in Financials. When a check is logged, it is now "tagged" to the protocol completely. If there are multiple studies associated with the check, the check will be split between the studies. This solves the problem of fundes that are Unallocated (not tagged to any study yet), and which study they belong to. Funds tagged to one study can be transferred over to another study as needed. Either way, funds will *always* be associated with some study.
IDEA:
1. See CREDIT items: 1, 2, 3
IRBANA:
1. See CREDIT items: 2, 3
BIOSPEC:
1. See CREDIT items: 1, 2, 3
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04/26/2014
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CREDIT:
1. There is a new section in File Ops > IRB > Edit Hospital\Affiliate. At the bottom of the page lists the studies in the system that the Hospital selected does NOT have access to. Directly on that page studies can be selected to provide access. Of note, the Hospital Status for the Studies selected will be Unassigned.
2. Current Status Report > IRB of Record now allows for Multi Selection.
3. Staff report multi selection of Staff is now available.
4. Financial Report: The Payables: Account Line Item now has the option to "sort by" the Service Provider and then show the totals per Service Provider.
5. The Payables: Account Line Items now has additional Columns to Include:
Patient Name
Patient Protocol/study ID #
Allocated Funds per event
6. For a given study, there might be 50 IRB AEs (Safety INDs) that come from the sponsor. Given that, they need to make one single log entry, and indicate that the there are "50" entries attached as a document. This is important as the Financials can then pick up the one IND and count it 50 times for funding.
7. As patient events are checked off in their calendar, the system is now capturing the Date the event was checked by staff. That new field can now be displayed in the Master Schedule Report as a Column to Include.
8. There is a checkbox to import the Cost Center into the Invoice Payee (Right side).
[ ] Include the Cost Center
9. When working in the Protocol Arms Design Module, when Importing Events from One Arm into another, the Billing Compliance Setting is now also imported. There is also a checkbox that allows for the event to be completely "Scheduled" on the Rainbow page when it is imported. This eliminates the need to re-check boxes on the new arm to match the donor arm.
10. When checking off patient events, if the "Billing Compliance" setting for the study is "Enabled", there is an Email that can be sent to the Billing Department directly from CREDIT. This is not new. What is new is the ability to Export to Excel. This way, once the schedule is generated it can then export it to excel and manipulate as needed.
11. "Undefined" has been added to the protocols drop down box on the Pre-Study Patient report.
12. The Protocol Design "Billing Compliance Grid" can now be filtered for specific events. There is a float bar for that purpose. Finally, the selection is saved in Memory per staff and Protocol\Arm so the setting will remain when the report is re-run by that staff.
13. Protocol "Event Notes" now show up on the Billing Compliance Grid.
14. The Report Protocols by Date now allows for multi-selection of hospitals. Hospital is now a Column to Include in that report as well.
15. Patient Calendar Manually Entered Events can now be tagged for BIlling Compliance (SOC vs. Research).
16. The Financials "Accrual" page now has the ability to Collapse and Expand the various sections of the page. By default, they are all Collapsed. There are 2 links at the top of the page, one to Expand All, the other to Collapse All. Also, each section has an arrow that will toggle the section to Expand or Collapse. Whatever the state of the page is, if changes are made, the "Update Reporting Info" button will save all sections.... even if they are Collapsed.
IDEA:
1. See CREDIT items: 2, 3, 4, 5, 6, 8, 9, 12, 13, 14, 16
IRBANA:
1. See CREDIT items: 2, 3, 4, 5, 6, 8, 14, 16
BIOSPEC:
1. See CREDIT items: 2, 3, 4, 5, 6, 8, 9, 14, 16
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03/29/2014
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CREDIT:
1. There is a new Financial Invoice Footer Macro: @InvoiceFooter. To support the Macro, there is a new button on the Invoice page, upper right: "Footer Macro". Click the button to add Institution & Protocol Specific information that will be brought into the Footer via the "Invoice Footer" button using the Macro noted above. As a note, the Invoice Footer is Department Specific. That means whatever is in there, is in for All Invoices for the Department of the Study. The difference with the Footer Macro, is that it is for All Invoices for *this* Study in *this* Institution.
2. Over the next few updaters, you will notice that many of the Date type fields now have a Calendar Date-picker popup. Simply click on a given date, and the Date Field will populate for you.
3. The Patient Calendar Cascade now has forward and backward arrow links to reload the page and move the display calendar several months forward or back.
4. The Protocol Current Status Report now includes the Protocol Site Number as a column to include.
5. There is a new option for allowing the Patient Protocol Page (Event Focus) to send emails to staff depending on a new setting in System. Upon saving, interrupt to send email when these values are changed:
Medical Record Number
On Study Date
Off Treatment Date
Off Study Date
Patient Status
When checked, there is an Email Inturupt that stops the saving, allowing the user to review the email to be sent (as well as select staff to notify). Once that page is saved (Continue), the email will be sent. By default, this feature is disabled (no boxes checked), and no email notifications will be sent.
6. The Protocol Arms Page can now have the Billing Compliance Page filtered to show\hide elements from displaying.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6
IRBANA:
1. See CREDIT items: 1, 2, 4
BIOSPEC:
1. See CREDIT items: 1, 2, 3, 4, 5, 6
GENERAL HELP:
1. We have a "Help" tool for assisting loading Protocol NCT Numbers. We have been working for a while now building over 1000 NCT Numbers. This web tool will pull all studies onto one page where the NCT Number is blank.
Then, one by one, do a lookup to see if that Study Number is in our database.
If it is, it populates that line entry on the page, allowing you to overwrite it or accept it.
Once saved, the page returns with those still missing the NCT Number.
They can be looked up on clinicaltrials.gov, and pasted into the CREDIT Web page.
Save again, and the number of studies continues to shrink.
Stop at any time and continue at a later date.
If you are interested in having this NCT Tool installed, please contact Stephen.Burke@ddots.com.
2. There is a new "CREDIT Introductory Guide: Protocols" available for Download at:
https://www.ddotscredit.com/DDOTSHelp/DocumentsPage01.cfm
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03/15/2014
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CREDIT:
1. The Protocol Current Status Report now includes new columns for "Cost Center Close Date" and "Disease Descriptor" (if this feature has been enabled in File Ops).
2. There a new Protocol IDE Number that can be turned on via File Ops > System > System Variable Default. Then, in the "New Patient Form" the number can be pulled in via the macro @IDENumber.
3. The IRB Log Adverse Event and the Patient Adverse Event Log have a new: Date of Report.
4. In the Billing Compliance Email sent when Patient Events are checked off, the email now includes the Protocol NCT Number.
IDEA:
1. See CREDIT items: 1, 2, 3, 4
IRBANA:
1. See CREDIT items: 1, 3
2. The Report Meeting Documents for Review now has optional "Order By" selections. The output page also states the Annual Review Expiration Date.
3. The Report Meeting Documents for Review also has new Color Keys and a Header for each submission to indicate what type of submission it is. So, as an example, the user asks for ALL TYPES on one page, they will see header and color change as they pan from one Type of Submission to another.
BIOSPEC:
1. See CREDIT items: 1, 2, 4
2. The Report Module for BIOSPEC has been expanded.
GENERAL HELP:
1. We have a "Help" tool for assisting loading Protocol NCT Numbers. We have been working for a while now building over 1000 NCT Numbers. This web tool will pull all studies onto one page where the NCT Number is blank.
Then, one by one, do a lookup to see if that Study Number is in our database.
If it is, it populates that line entry on the page, allowing you to overwrite it or accept it.
Once saved, the page returns with those still missing the NCT Number.
They can be looked up on clinicaltrials.gov, and pasted into the CREDIT Web page.
Save again, and the number of studies continues to shrink.
Stop at any time and continue at a later date.
If you are interested in having this NCT Tool installed, please contact Stephen.Burke@ddots.com.
2. There is a new "CREDIT Introductory Guide: Protocols" available for Download at:
https://www.ddotscredit.com/DDOTSHelp/DocumentsPage01.cfm
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03/01/2014
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CREDIT:
http://www.ddots.com/credit_overview.cfm
1. The Protocol Research Team module now allows "Mimic" from one study to another. Previously, it only allowed Mimic from one Hospital to another (via the same protocol).
IDEA:
1. See CREDIT items: 1
IRBANA:
1. See CREDIT items: 1
BIOSPEC:
1. See CREDIT items: 1
GENERAL HELP:
1. When making changes in Financials in the Protocol Design page, note that the Rainbow Page does not update $ values for events. So, when adding a new event to a study with patients already attached, check the boxes to plan the event out over time. Update the Patient Calendars, *then* go in and add the $ Amounts. By adding the $ Amounts *after* the patients get the calendar event loaded, those events will get updated in the patient calendars. This SOP is the preferred method of adding $ Values to a study with existing patients. 1. Create the event, and schedule it, updating patient calendars. 2. Edit the event(s) adding in the $ values. A notice will allow you to update those values in the patient calendars.
2. Support for Internet Explorer 6.x is done. That browser is over 13 years old, and DDOTS new features will not function in that old browser.
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02/01/2014
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CREDIT:
1. The Unanticipated Problems Log now allows for Multi-File Uploading
2. Notice to all organizations that use the Email Billing Compliance Notification System.
As you know, the $$$ values are encrypted such that the CREDIT Staff does not see them.
Then, when the email gets delivered, the values are exposed.
Starting this Thursday, January 23rd, only staff that have their profile Access Right set to Read or Write for: Financials: Show $ Values on Events will be able to see the values. This means your Billing Group need that setting in their staff profile.
Likewise, any staff that should *not* see the values, even if they email themselves, will still have them encrypted.
3. There are several new Macros available for a new Request For Payment (FRP) merge. This allows for the creation of a custom RFP Form built in the Documents Module. The Macros are:
@RFPDate
@RFPNumber
@RFPGrandTotal
@RFPName
@RFPStreet
@RFPCity
@RFPState
@RFPZipcode
@CostCenter
@RFPAccountXX (01 thru 10)
@RFPEventPayableXX (01 thru 10)
@RFPDescription
For this system to work, there is a setting in File Ops > System > System Variable Defaults > Financials > Request For Payment Uses Built-in Default Format it is Defaulted to Enable. When Disabled, the system looks into the Documents Form Module for the User to select the RFP Form for Merging.
http://www.youtube.com/watch?v=CpqOo6hStnQ&feature=youtu.be
4. There are several new fields available on the Invoices for studies. The default values can be stored (optionally) in the File Ops > Edit Department module. The fields are:
Prime Award Number
Awarding Agency
Source of Funds
Subaward Period of Performance
Subaward Number
CFDA Number
Tax ID Number
Purchase Order Number
5. If a Study is set to Patient Age Restrictive, there is an Email Notify when Patient turns: ______ (18) option. Now, 90 days before that birthday for a patient, an email will be sent to staff (who are on the Notify Patient Birthday list) giving them notice of the upcoming event.
6. DDOTS has been working with the Epic Team in Memphis (Baptist). We are finalizing the physical movement of data between the systems. As a result, some of the DDOTS Systems have changed slightly. One is that in the Protocol Research Team, you cannot simply select a different "Contact Type) for an existing entry. As an example, a Sub-PI is now taking over, and is the PI. To now make this happen, the Sub-PI must be Removed, then Re-Loaded. The Re-Load Action (if the Epic Communicator is installed) sends an update that there is a new PI for the study. While this is a little more work, it is an important element to keep Epic and CREDIT in Sync.
7. The Main Menu Link for "View Staff Events" has now been expanded to allow for reviewing Staff Assigned Tasks via the "Time Task Recorder".
http://www.youtube.com/watch?v=WwktboPCTuk
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7
IRBANA:
1. See CREDIT items: 1, 2, 3, 4, 6, 7
BIOSPEC:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7
GENERAL HELP:
1. We are completing our interface with Epic. Be aware that some pages might have slight changes to facilitate that process.
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01/18/2014
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CREDIT:
1. There is a new "Unanticipated Problems" report available.
2. There has always been the option of Enabling "Show New Patient Form Button on Patient Protocol Page" in the File Ops > System > System Variable Defaults > Patient\Study. Now, however, if this feature is Enabled, the output form can be exported to Word for further editing as needed.
http://www.youtube.com/watch?v=ObtYFRhwsqs&feature=youtu.be
3. The Main Menu has had a small but powerful link on it for several months. "View Staff Events" link opens up a listing of all patient calendar events for the logon staff. Optionally, there is a tab for "All Patient Events" that does not filter patients per the logon staff. Now, there is a new tab: "Data Management Log" that displays all Forms that are due to be submitted in the date range. The Date Range is established by the "Configure" tab.
http://www.youtube.com/watch?v=3t20YnLbEus&feature=youtu.be
4. There are 2 new CREDIT Introductory Guides available via the Help System. Pre-Study & Patient File Cabinet.
http://www.youtube.com/watch?v=NCguD61eEsQ&feature=youtu.be
5. On the Protocol Data Page, there is a new Date field that can be Enabled: Target Accrual Completion Date. It is Enabled via File Operations > System > System Variable Defaults.
http://www.youtube.com/watch?v=QwaEEaWf10o&feature=youtu.be
6. There are some new Macros available for File Merge via the Documents Module:
Target patient accrual completion date @TargetAccrualCompletionDate
Target patient accrual number @TargetAccruals
The number of patients that were enrolled in a study since the last continuing review ??? @YearPatientCount
The number of patients that were enrolled in a study to date (Pulled from Submission) @PatientCount
The total number of patients approached to enroll in the study (Prestudy Count) @PrestudyCount
The number of AE’s (internal) that occurred at St. Luke’s @LocalAECount
7. The Protocol "IRB: Follow-up Sheet" can now be globally filtered to hide specific data tables that are not desired to be printed. File Ops > IRB > IRB Meeting Environment > Optional Pages to Include in Protocol Follow-up Sheets.
IDEA:
1. See CREDIT items: 1, 2, 3, 5, 6
IRBANA:
1. See CREDIT items: 1, 5
BIOSPEC:
1. See CREDIT items: 1, 2, 3, 5, 7
GENERAL HELP:
1. There are 2 new Introductory Guides (Prestudy & Patients) available in the Help System from within any DDOTS System. Help (icon) > DDOTS On-line Documents. Look for CREDIT Introductory Guide: ___________ (all files are listed alphabetical).
2. How to Enable and use the Protocol NCT Number field.
http://www.youtube.com/watch?v=WOoqi-E2Acs&feature=youtu.be
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01/04/2014
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CREDIT:
1. There is a new feature in the Protocol Arm Design Page (Rainbow Page) that allows an Unscheduled Event to "Mimic" an existing scheduled event. For an event to qualify for mimic, it cannot be scheduled in any of the date "Segments" for the Arm. If that is true, an new link "mimic" is displayed under the event name. When clicked, a dropdown box is exposed that displays all events that are currently scheduled for the Arm. Selecting an event, and clicking a Save and Continue button will update the event, shadowing the selected event for the mimic. http://www.youtube.com/watch?v=QGg92xR9nIY&feature=youtu.be
2. The Staff License Report now allows for Exporting to Excel.
IDEA:
1. See CREDIT items: 1, 2
IRBANA:
1. See CREDIT items: 2
BIOSPEC:
1. See CREDIT items: 1, 2
GENERAL HELP:
1. How can I "Bulk Record" IRB Meeting Activities in my system? I know how to do them one-at-a-time via searching for each study and drilling down to the specific Submission, but that takes a little more time than I have.
http://www.youtube.com/watch?v=AOujC1bGPEc&feature=youtu.be
2. How can I set up Billing Compliance on Protocol for Patient Billing Compliance.
Part 1: http://www.youtube.com/watch?v=vC9b2zVjpMk&feature=youtu.be
Part 2: http://www.youtube.com/watch?v=KJxWLKKGi5U&feature=youtu.be
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12/21/2013
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Paste the "http://wwww.youtube.com/........." links below into your browser to view videos detailing the specific update.
CREDIT:
1. There is a new section available in the Patient Demographic Page (Photo Page): Substance Use. For this feature to show up, it needs to be Enabled via: File Ops > System > System Variable Defaults > Patient/Study > "Show Patient Tobacco Use" and\or "Show Patient Alcohol Use". http://www.youtube.com/watch?v=_15WzCDilbs&feature=youtu.be
2. If the Protocol NCT Number is Enabled in File Ops > System > System Variable Defaults, then that number is now a "peek-thru" on the Patient Protocol Page. http://www.youtube.com/watch?v=Giik3YQmQBk&feature=youtu.be
3. If the "New Patient Form" is enabled in File Ops, there is a new Macro available "@NCT" which is the NCT Number for the study. Note that the NCT feature must be Enabled per #2 above.
4. The Protocol Mini-Menu Logs can be Re-titled. File Ops > System > System Variable Defaults > IRB Activities: toward the bottom of that section, the following can be re-titled:
IRB: Review History, IRB: Revision Log, IRB: Adverse Events, IRB: Unanticipated Problems. Re-titling them will have them display with the new titles in the Mini-Menu only. There is no follow through to the pages nor to reports. http://www.youtube.com/watch?v=_khHuECQ1RU&feature=youtu.be
5. If the System Setting "Show Patient Consent Date on Patient\Protocol Page" is Enabled, the On Study Date is Compared to the Consent Date. If the Consent Date is newer than the On Study Date, an Alert box is shown to tell that it is not allowed. There is a new System Setting that can now Disable that comparison feature. File Ops > System > System Variable Default Values > Patient/Study > "Check For Consent Date On\Before On-Study Dates". By default it is Enabled.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5
IRBANA:
1. See CREDIT items: 4
2. Each IRB Reviewer can now check-off that the Documents for Review are completed. Each Reviewer can only check their specific box as completed. Each Reviewer will see which other assigned Reviewers have or have not completed the Review. The Administrator can check of un-check any Completion Box for any Reviewer. http://www.youtube.com/watch?v=ADSl75J_WBg&feature=youtu.be
BIOSPEC:
1. See CREDIT items: 1, 2, 3,4, 5
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12/07/2013
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CREDIT:
1. If there is a MedWatch Number assigned to a Safety IND\Patient Adverse Event, that number will be displayed in the Financials when Milestones are Collected.
2. Patient Document Uploads now have the ability to assign a Folder to each uploaded document.
3. When an Invoice or Request For Payment is created (PDF), there is now an option to directly Email the document.
4. The Staff License Report can now be run via Date Range for Expiring Licenses.
5. For CCOPs, the NCI just released the latest version of their "Crediting" database. It is currently upgraded into your system. Should you have any issues with the NCI Report, contact your "Go-To" DDOTS Staff.
IDEA:
1. See CREDIT items: 1, 2, 3, 4
IRBANA:
1. See CREDIT items: 3, 4
2. The Agenda can now have Document Links imbedded directly in the Output. There is a new "Macro" in the Agenda Format module that allows for "IRB Documents". When that is part of the Agenda, and the link for a document is hit, a new popup window is launched with the document and a listing of Staff who downloaded and Reviewer Comments.
BIOSPEC:
1. See CREDIT items: 1, 2, 3, 4
2. A zero quantity can now be loaded in as a Blood Sample volume. This allows for the logging of the activity with zero quantity usable resulting.
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11/23/2013
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CREDIT:
1. The Pre-study Patient Report can now be filtered per "Continue Contact" via the Demographic page or Workup pages.
2. There is a new Column to Include in the Protocol Current Status Report: "Outstanding Issues". If there is any data in the Issues box, it is displayed. If the box on the protocol data page is checked to indicate an "Outstanding" issue, the font color on the report is red.
3. The Protocol Acuity Ranking section has now been expanded. There is a new "Target Acuity Ranking" which is what might be published about the study. And an new "Regulatory Acuity Ranking" can also be set to be included in the overall "Current Acuity Score" for each study.
4. The Current Status Report now includes Columns to pull the Acuity Scores per study.
5. The Current Status Report now includes all Research Team "Contact Types" as staff Columns to Include.
6. If the Protocol Patient Age Range is enabled, it can now be set to Months vs. Years. This is to allow COG studies that have age ranges from 6 Months thru 18 Months.
7. The Financial Cash Receipts Journal is now Date Ranged.
8. When deleting a Deviation that was originated on the Patient Side and Created and IRB Entry, there is now a prompt to Delete both the IRB submission and the Patient side entry, or simply the Patient side entry, leaving the IRB Submission in place. The same is true on the IRB side. If a Deviation is being Deleted where a Patient Entry also exists, there is a prompt to also delete the Patient Side entry, or not.
9. The IRB Revision Log now has a link to display the Notified Staff.
IDEA:
1. See CREDIT items: 2, 5, 6
IRBANA:
1. See CREDIT items: 2, 7, 9
2. The Report New Documents for Review has been updated such that Reviewers can not check a button to indicate "Review Completed".
3. IRBANA Staff can also go into the New Documents for Review and set the Action, Reviewed By, and update the Agenda right on the fly for each study. This eliminates the need to run the IRB Meeting Activity Report for Expedited Submissions.
BIOSPEC:
1. See CREDIT items: 1, 2, 5, 6
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10/19/2013
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CREDIT:
1. There is a new data table "Morphology", and it has been populated from the World Health Organization database. It has been Enabled such that all can see it on the Patient Protocol Page. It can be turned off via: File Ops > System > System Variable Defaults > Patient\Study > Show Patient\Protocol Morphology > Disable. There is also a new link in File Ops > Patients > Edit Morphology for Patients. By default, all entries are "Active". By clicking on the upper right corner link on the Edit page, SHOW EXISTING FILE. On this page, selections can be set to Inactive by un-checking the Active box next to the entries. SAVE at the top of the page updates the database.
Then, the Patient\Protocol page dropdown box will only contain those Active Morphologies.
2. The Patient\Protocol "Disease Site" can now be re-named via: File Ops > System > System Variable Defaults > Patient\Study > Patient/Study Diagnosis Title. By default, it is set to "Disease Site". Some installations want to rename it to "Typography".
3. The Prestudy List Report can now be filtered for Do-not-contact vs. Continue-to-contact.
4. On the Patient Demographic Page, if there are Workups in Prestudy for the Patient, the Workups are displayed under the "Go There" link into Prestudy for the patient.
IDEA:
1. See CREDIT items: 1, 2, 3
IRBANA:
1. See CREDIT items:
BIOSPEC:
1. See CREDIT items: 1, 2, 3
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10/05/2013
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CREDIT:
1. If the NCCCP Log ID is enabled for Prestudy Workups, that ID will now display with the workup on the Prestudy Patient Demographic Page.
2. There is a new "Patient Last Name Alias" field available in both Patient and Prestudy Demographic pages.
IDEA:
1. See CREDIT items: 2
IRBANA:
1. See CREDIT items:
BIOSPEC:
1. See CREDIT items: 2
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09/21/2013
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CREDIT:
1. User Defined Fields can now be targeted to Protocol\Hospital. This means that a new field can have different input values for each Institution for a given study. File Ops > System > User Defined Fields.
2. When selecting a Staff in File Ops > Staff > Edit Staff and Assignments, resigned staff are colored red with their resigned date displayed as well. Logon staff have their background color set to light blue. Other staff are normal black and white.
IDEA:
1. See CREDIT items: 1, 2
IRBANA:
1. See CREDIT items: 1, 2
BIOSPEC:
1. See CREDIT items: 1, 2
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09/07/2013
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CREDIT:
1. There is a new "Protocol Acuity Ranking" available. First, it must be Enabled via: File Ops > System > System Variable Defaults > Protocol Data > Protocol Acuity Ranking > Enable. Then, below that option are 3 Levels of Acuity: Active, Short-Term Follow-up, Long-Term Follow-up. Select the Patient Statuses that apply to each level, being careful not to duplicate the Status Selections in each section.
When Saved, the Protocol Page will then display the 3 Levels of Acuity allowing for a drop-down selection from 1-10. Once that page is Saved, the Patients attached to the study will be inspected and evaluated via their Protocol Status and the "Acuity Ranking" will be calculated based on the scores of all patients that match the list of Status assigned in File Ops from above.
IDEA:
1. See CREDIT items: 1
IRBANA:
1. See CREDIT items:
BIOSPEC:
1. See CREDIT items: 1
Steve-
Ph: 734.434.7734
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08/24/2013
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CREDIT:
1. There is a new Staff Access right in each staff profile for Read\Write "Patient Audit History".
2. The Protocol Unanticipated Problems Log can now be Disabled via: File Ops > System > System Variable Defaults > Protocol Data > Show Protocol Unanticipated Problems Log.
3. The limit of Prestudy Bulk Workups per entry can now be set via File Ops > System > System Variable Defaults > Prestudy >Prestudy Bulk Workup Replicate Limiter. The Limiter can be set in a range from 1 to 200.
4. The IRB Document Library now allows for "Bulk Downloading". There is a new checkbox across from each Document. When selected Documents are checked, a new "Download Selected Files" button submits the page and bulk downloading begins.
IDEA:
1. See CREDIT items: 1, 2, 3
IRBANA:
1. See CREDIT items: 2, 3
BIOSPEC:
1. See CREDIT items: 1, 2, 3
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08/10/2013
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CREDIT:
1. There is a new Financial setting available in the System Setup. File Ops > System > System Variable Defaults > Financials > Show Financial Balance in Toolbar. This feature will turn on a small snapshot of totals for Invoices, Payments Allocated, Account Receivable, Payable, Account Financial Balance. These values are on the Toolbar when inside of any study Financials Pages.
2. The Research Team selection box is now filtered to load only staff who have not Resigned.
IDEA:
1. See CREDIT items: 1, 2
2. Drug Inventory can now be Quarantined via the "View Drug Inventory & Locations" page.
3. Pharmacies can now be set to Active vs. Inactive. File Ops > IRB > Edit Hospital\Affiliate\Satellite > (choose hospital) > Select Pharmacy and EDIT.
IRBANA:
1. See CREDIT items: 2
2. Revision & Review Emails can now include the "Non-Agenda Notation" per a new checkbox to Include.
BIOSPEC:
1. See CREDIT items: 1, 2
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07/27/2013
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CREDIT:1. The Financial Account Line Items can now be associated with a specific Hospital via File Ops > Protocols >. If the association is made, during Invoice Milestone Collection, only the Account associated with the specific event will be available for selecting. By default, all Accounts are available on all Invoice Lines.
2. If the Patient Protocol "Schedule Starts" date is enabled, that date can be set back before the On Study Date if the File Ops > System > System Variable Default Values > Patient\Study > Patient Schedule Start Days Beyond Onstudy Date Validated for: is set to a negative value. Typically, COG studies are allowed -5 days before the date of registration.
3. The Patient Protocol Data Management Log now allows for the existing entries to be sorted via header links in the display table.
4. There is a new System Setting to Enable\Disable "Anatomical Locations" in Prestudy Workups.
5. The Financials Toolbox (bottom bar) now displays "Invoices-Payments=Receivable" information.
6. The Prestudy Report now allows for filtering via the Screening Date.
IDEA:
1. See CREDIT items: 2, 3, 5, 6
IRBANA:
1. See CREDIT items: 1, 2, 5
BIOSPEC:
1. See CREDIT items: 1, 2, 5, 6a
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06/29/2013
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CREDIT:
1. There is a new Financial Report: Invoice Adjustments. When Adjustments are made to existing Invoices, CREDIT can capture the changes and this new report summarizes the Adjustments per Date Range.
2. In each Staff Profile (File Ops), the Hospital Listings are color coding to denote IRBs vs. Non-IRB Institutions. This is now consistent with the popup window requesting Hospital Selection when entering the Patients or Protocols Modules
IDEA:
1. See CREDIT items:
IRBANA:
1. See CREDIT items: 1
BIOSPEC:
1. See CREDIT items: 1
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06/15/2013
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CREDIT:
1. The Invoice Aging Report now has the Date Range showing in the Table Header. This helps when Export to Excel is requested, as the date range will be included in the Export.
2. The Invoice Aging Report now allows for Aging thru Today vs. the selected End or "Thru" date.
3. If enabled, the Protocol Sequence Number is now available as a Column to Include in the Invoice Register Report.
4. There is a new System Setting that allows for turning Off the Numbering of Documents in the IRB Document Library. Often Documents get put into various folders and the Numbering Sequence seems to be off. This feature allows for that column to be hidden. File Ops > System > System Variable Defaults > IRB Activities > Show IRB Document Numbering on Documents Page
5. The Financial Invoice by Payor report now allows filtering per Department.
6. There is a new Automatic Email Notification of Expiring Continuing Reviews to selected Staff. Emails can be sent multiple times (as needed) in 30 day increments. There are 2 sets of Staff Selections to get the emails. First is a simple selection of staff, the second is the Contact Types of staff for each study (i.e. PI, Coordinator, etc...), File Ops > IRB > IRB Meeting Environmental Defaults > Expiring Study Notifications.
7. The Protocol Receivables Report now allows for "Begin Display Date". This way the Start Date can be set to 1900, and Begin Display at April 1, 2013 with Stop Display set to April 30, 2013. The report will roll up all of the data between 1900 and March 31, 2013 and show "Starting Totals". Then the month of April data will display with a total for that date range. Finally the "Closing" Balances are summed up. Additionally, this report now can pull "Invoice Adjustments" made during the Display Date Range. So if staff adjusted an invoice on April 5th from an Invoice Dated January 4, 2013, that "Adjustment" will be displayed showing the details of what was adjusted, and by which staff.
8. The Patient Protocol Page now displays any Ancillary or Other Studies of Interest in the top left corner. If studies are listed, they are linked to pop-up the Protocol Data page. Also, if Patient Forms are available for the studies, there are buttons to pop-up a window of links for those forms.
9. On the Protocol Data Page, the button to Show Patients now has a new feature in the pop-up window. After the patient listings, there is a new data table displaying the Institution and the count of Patients for each Patient Status. This feature can be "Disabled" via File Ops > System > System Variable Default Values > Protocol Data > Show Patient Arm Attachment Hospital & Status Table
IDEA:
1. See CREDIT items: 8, 9
IRBANA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7
2. New Macros for Letter Generator: @IRBMeetingWordDate and @IRBMeetingWordDate(XX). These produce the date in "Word" or "String" format: January 15, 2013. This as apposed to @IRBMeetingDate which produces: 1/15/2013.
BIOSPEC:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7, 8, 9
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06/01/2013
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CREDIT:
1. The "My Tasks" listing above the Main Menu now includes Prestudy Workups where the "Re-contact" date is involved.
2. The Patient Checkoff Calendar now displays the number of days "Cascaded" if the Event has been delayed.
3. If the IRB Reviews or IRB Revisions are involved in either an Invoice or Request for Payment, the entry cannot be deleted. To allow it to be deleted, first the Invoice or the RFP must be detached.
4. The IRB Document Library can now be sorted "Descending" per some of the dates.
5. If IRBANA is installed, the IRB Document Library now displays Yes or No in the new display column "New Document for Reveiw".
IDEA:
1. See CREDIT items: 2
IRBANA:
1. See CREDIT items: 3, 4
BIOSPEC:
1. See CREDIT items: 2
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04/29/2013
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CREDIT:
1. The IRB Document Library now has Sub-Headers listed in the Check Box Columns to assist users as to the function of each box.
2. The Protocol Current Status Report now has Sponsor Affiliation as a Sort option and Column to Include.
3. The Time Task Report now exports to Excel.
4. The IRB First Review Report now includes the First Patient Accrual Date and the duration in Years and Days from the original approval to the first accrual.
5. The IRB Review History "CTSU Withdrawal Form" checkbox can now be hidden via new System Setting.
6. The IRB Revision Log "Schema Change" data line can now be hidden via new System Setting.
7. When uploading Documents via the Regulatory Logs, Institutional Access can now be provided at the time of upload. Historically, the process required first uploading the document, then going into the IRB Document Library and Editing each entry to assign Access Rights.
8. The Protocol Current Status Report now has the AFFILIATION as a Multi-Select box.
9. There is a new module in the Financials System. When an Invoice is Edited, the user can now "Log" the invoice adjustment in a new log file. This is helpful in this way: If an invoice from 2009 had a balance of $50 for a given event, and the Sponsor should not (and will not) pay for it, that event needs to come out of that historic invoice. But doing so modifies the AR carried forward month to month. Now, the removal is balanced with the new Invoice Adjustment Log that demonstrates that the AR carried forward was adjusted by $50 due to the removed historic event. All data per that removal is captured. There is a new link on the Invoice page between where the Invoices end and the Payments begin. That link, when clicked, show any Invoice Adjustments to that study.
10. In Prestudy, if the Patient has been activated to studies, there is a new link to popup "Patient Study Activations". When clicked, a window loads with all of the studies the patient is associated with. The list is filtered to the User Hospital and Department List Access.
11. The Patient Documents that link to the Patient Consent Form Log now have a link in the Log to download the Patient Document.
12. The Patient Requisition Report now has the ability to capture the Prestudy Requisitions as well.
13. Financial Invoices can now display the Sponsor Site Number. It is in the Payee Info Popup Window.
14. There is a new Staff Access for the Report "Staff Licenses". So if you find it missing, simply edit your staff profile and check the new Access Box for that report.
15. There is a new System setting that Defaults the Patient Calendar pages to "Show Notes". By default this option is "Disabled", meaning when a patient calendar page loads, the "Show Notes" checkbox is unchecked.
IDEA:
1. See CREDIT items: 2, 3, 8, 11, 12, 14, 15
2. Each Pharmacy can have a "Default" DAR Note established in File Ops > Pharmacy > Edit Pharmacy Environment Defaults. Having a Default Note can prompt staff to fill in blanks that the template provides, allowing for a more complete and consistent set of notepads in each Pharmacy Study.
3. There is a new "Filter" link available on DARs. New options for display vs. hiding types of events are available via that link.
4. - For the Pharmacy Notes for each protocol in the Pharmacy, you can set the site code on a sponsor and it'll default over to the protocol page, where you can change it if needed. If the sponsor is changed there, it'll reload the site code on the study page, so heads up.
- There is a @SiteNumber macro to add this automatically to the pharmacy notes.
- To undo a patient return, go to the patient returns page from the mini menu and click through the new "undo" link. It'll undo the associated destroy also.
- Bottle IDs are now on the on the PDF DARF.
- More filter options on the web PDF for DARFs.
5. The Protocol DAR Menu page now displays the Patient Arm for each Patient DARF. This is also true on the Patient DARF.
6. Patient Returns can now Return zero quantity (empty) bottles.
IRBANA:
1. See CREDIT items: 1, 2, 3, 5, 6, 7, 8, 9, 13, 14
2. IRB Document Comments can now be Deleted. This is a new Staff Access right and must be assigned for staff to use this feature.
3. IRB Revision Log "Toxicity List" can now be hidden via new System Setting.
4. In the IRB Document Library, the checkbox for New Documents for Review can now be cleared with a single click.
BIOSPEC:
1. See CREDIT items: 3, 8, 11, 12, 14, 15
2. Subsets of Tissue now inherit attributes from the Parent Sample.
3. There is a new "Floating Save" bar to facilitate quick saving. Once saved, the current page is refreshed rather than closed.
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02/23/2013
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CREDIT:
1. There is a new "IRB Forms" Link on the Main Menu. This title can be changed via File Operations > System > System Variable Default Values. The function of this new module to allow the upload/download of various Non-Protocol Specific Documents. So, basic SOPs, standardized IRB Forms, Instruction Sets, etc., can all be organized there. This system is available in 2 areas.
In the Reports > General > Generic Document Upload, users can Upload and Download various documents. Then, as needed, "Move" the Document(s) into the "IRB Forms" module from the Main Menu. Think of the Reports module for this as a general catch-all until such a time that they need to be organized into the IRB Forms Module.
2. If the site has "Show Protocol Expiration Date" Enabled, the system now allows for Emails to be sent to various staff xxx Days ahead of Expiration. To Enable and Set up this environment: Main Menu > File Ops > IRB > Edit IRB Meeting Environment Defaults (as this is IRB Specific) > Expiring Study Notifications where the Staff to Notify are established as well as the frequency of emails (120, 90, 60, 30, Expired). Each has a check box, and they can be checked as needed. If none are checked, the system is Disabled.
3. Via File Operations, CPT Codes can now be added to various Labs and Procedures. Those code then map over to the Protocol Rainbow Page for Financials. The codes then propagate into the Patient Calendars. If "Patient Billing" is enabled on the Protocol (previous update), those codes are included as part of the Email that goes to the Billing Department.
4. The Patient Check-off Calendar has been upgraded to process the "Save & Continue" significantly faster.
5. The Main Menu now has a new link to "View Staff Events". The link opens up a window that displays staff current Patient Load for the next 7 days (default). There is also a tab for showing ALL Staff Events. Clicking that tab will load all Patient Calendar Events coming up in the next 7 days (takes about 30 seconds to load). There are quick links in the window that allow for going to various pages within the system.
IDEA:
1. See CREDIT items: 1, 5
IRBANA:
1. See CREDIT items: 1, 2
BIOSPEC:
1. See CREDIT items: 1, 5
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01/26/2013
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PLEASE, encourage your logon staff to use the "MY ACCOUNT" button in the upper right of the Main Menu to add their Email Address into the System. This helps us communicate directly with staff if they have a problem inside of a DDOTS System.
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CREDIT:
1. There is a new module in the Patient & Protocol systems: "Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs)". This new log allows the capture of events that need to be associated with either Patients or Protocols. Like the Patient Adverse Event System, creating an event in the Patient Record can also create an IRB Entry.
2. If a Financial Payment is split to multiple Protocols, and there have been no Allocations to the other Protocols, there will be a simple check box with "Del." allowing the user to remove the attachment to the other studies. If there have been Allocations to the other study per the Payment, there is no "Del." checkbox.
3. The Report Invoice Generator has 2 new Columns available to include: Protocol Status and Financial Status.
4. The IRB Document Library now allows for each Document to be "Commented". There is a new Pencil icon that opens up a small comment box with a Save button.
5. Over the past few updates, 2 new data tables have been added: Prohibited Drugs (assigned at the Protocol Arm Level), and Con Meds (assigned at the Patient Protocol Level). If staff loads Con Meds in a patient record, and the med being loaded is in the Prohibited Listing, staff is alerted and the Log Entry alert turns Red in color.
6. When adding a Workup for a prestudy patient, an Email can now be generated about the Workup.
IDEA:
1. See CREDIT items: 1, 5, 6
IRBANA:
1. See CREDIT items: 1, 2, 3, 4
BIOSPEC:
1. See CREDIT items: 1
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01/12/2013
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CREDIT:
1. The Mobile Application now includes the contact information for staff assigned to each Patient\Protocol Page.
2. For the IRB Follow-up Sheets, if the Patient Status Summary Box is Enabled, the listing in that box can be changed from showing Multiple Arm Status per Patient (default) to Distinct Patients only. File Ops > System > System Variable Defaults > IRB Activity > Protocol IRB Follow-up Sheets Distinct Patients Only
3. For NCI CCOPs, if Credits are associated with the patient check-off calendar, the NCI Name of the Credit now displays along with the Type and Value.
4. There is a new system to manage Reports. Located in File Ops > System > Setup Reports. This new module allows for renaming the actual Reports. Also available is the ability to provide "Information" about what the report will and will not do. Because this is a System Setting, the Report Names and Information are universally applied. Finally, within the module, Admin can "Order" the reports by moving them up or down in the Report List. This provides Complete Control over the Report Page Display.
5. There is a new System Variable that allows for ALL IRB Documents to be available via the Patient Consent Form Log. Prior to this, only Patient Protocol Documents were shown. If this feature is enabled "Show All Library Documents In Consent Log", all forms will be exposed for downloading. File Ops > System > System Variable Defaults > Patient\Protocol > Show All Library Documents In Consent Log. When disabled (default), only one Forms button appears in the Consent Form Log "Patient Forms". When enabled, a second button will appear "All Forms".
6. There is a new Report under the IRB Column "Document Download Report". It allows for pulling staff who downloaded IRB Library Documents, per Hospital, Department, Protocol, Sponsor, Date Ranged.
7. When Protocol Research Staff have assigned Capabilities, when an END Date is entered for the Capability, the dislpay has a Strike-Thru the specific Capability.
8. The Patient 1 and 4 Column Calendars now have a Floating Layer that allows for setting a Date Range for the page.
<>bIDEA:
1. See CREDIT items: 1, 4, 5, 6
IRBANA:
1. See CREDIT items: 4, 6, 7
BIOSPEC:
1. See CREDIT items: 1, 4, 5
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12/21/2012
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CREDIT:
1. When adding patient calendar Manual Events, there has always been a "Completed" box available to Complete the event on the fly, without having to open up the calendar to do so. Now there is a "Notes" box that is also saved with the event on the Patient Calendar.
2. When Emails are sent via IRB Reviews and Revisions, the Email now includes the IRB Meeting Date.
3. The Patient Adverse Event Log now allows for Document Uploading.
4. The Protocol Arm "Delete" button can now be globally hidden for all staff, all studies. By default this feature is set to Enable to Show the Button. To hide the button: File Ops > System > System Variable Defaults > Protocol Arms > Show Protocol Arm "Delete" Button (last entry in that section) Disable.
5. The Patient Requisition Report now includes filter capabilities by Patient or Protocol.
6. Prestudy Screening Workup can now have the Screen Date Required. The default is Not Required. To change this: File Ops > System > System Variable Defaults > Prestudy > (Look for Screen Date Required).
7. For Prestudy Patient "Continue to Contact", the only defaults were: User Must Choose, Continue to Contact, and Do Not Contact. A new option has been added and is managed in File Ops > System > System Variable Defaults > Patients > "Continue to Contact". The new default option is "Not Addressed".
8. There is a big change for CCOPs on how NCI Credit Names are assigned in the system. Originally, the NCI Report Name for Credits came from the Protocol Page. A few years back, it was changed to pull from the Arm of the study that the Credit was associated with. Today it is assigned per the Credit entry on the "Rainbow" Page. This way, each Credit event can have its own name for NCI Reporting. This eliminates the need to create separate Arms just to give the Credit a new Report Name for the NCI. As an example, Study AAML1031 has a Treatment Credit = 1.00RX. That same study has a QOL Component for 05.00CC. However, the "Name" for that QOL Credit has to be reported as "AML1031-QOL", while the RX Credit is simply "AML10301". With the new system, both Credit Events can be on the very same Arm, because each Credit can be assigned the specific name within the Arm.
Finally, the NCI Report for CCOPs has been re-directed to look into the "Rainbow" Page to pull the Naming for each Credit (instead of simply the study Arm).
9. There is a new System setting to allow for Multiple Protocol Workups in one single Workup Window. By default, this is Disabled. To Enable: File Ops > System > System Variable Defaults > Prestudy > Allow Multiple Prestudy Workups at One Time. When Enabled, the user simply selects a Disease Site for the Workup from the Prestudy Workup page. When the popup window loads, there will be a "Populate" box that allows for selecting Protocols (multiple) for screening. This way staff can screen for a selected Disease Site, and choose several Protocols to apply. When saved, there will be one workup for each protocol that was selected. From this point on, each workup is independent (not dependant on any of the originals selected). This will save staff time when needing to do several workups for a single patient/disease site.
This new system *only* works from the Patient Mini Menu > Workups Page. It is not available via the quick link on the Prestudy Patient Data Page.
10. There is a *lot* of interest in Sponsor Monitors doing their work from their offices instead of driving across the country to make physical audits. The idea is that a Monitor can be given logon with limited authority to get into CREDIT. Once in, they typically go to the Protocol IRB Modules and inspect the Follow-up Sheet with Document Links... something that they could do from home.
However, the problem is that the staff has to provide logon, then remember to go remove the logon and password... if they forget, it could be a violation. So, in the Staff Table, perhaps a Logon Authorization Date Range, as well as a Time of Day Range.
User can log on between (24 hour clock start and end). By default, current logon users have this Limiter Blank, resulting in unlimited date and time.
11. There is a new system for Protocol Arms "Prohibited Drugs", and they are available on each Arm of each Protocol. To facilitate loading all Arms, there is also an "Import" Prohibited Drugs from another Arm on the study. This makes loading quick and easy.
If there are Prohibited Drugs listed for a given Arm, and there is a Patient on that Arm, the list of drugs is now shown on the Patient Protocol Page (Event Focus box).
12. When Staff are assigned to the Patient Protocol (Investigator, RN, CRA), and if those same staff are in the Protocol Research Team page, if there are any "Capabilities" assigned on that Research Team Page, those Capabilities now "peek-thru" onto the Patient Protocol Page.
13. In the File Ops > Staff > Edit Staff and Assignments > Show Existing File: There is a new column "Email". If the staff email is in the system, the address is shown and is linked to open up a new message in the institution email system.
14. For recording "Minutes" on various pages (Consents, Time Clock, etc....) there is a new System setting. File Ops > System > System Variable Defaults > Consents, Calendar, Task Recorder "Minutes" Increment that can be set to 1, 5, 6, 10, 15, 20, or 30. This setting determines the breakdown of Minutes Display available in the dropdown boxes where Minutes are appropriate. By default, the setting is 15 Minutes.
15. IRB ORC Events have always been able to be tagged as a "Default". This ability (via File Ops) presents a button on the ORC Page to "Load Defaults". Clicking the button produced a popup with those ORC Events listed and ready to be populated into the ORC Page. Per File Ops > Edit ORC Events, the selected event can have Institution Access set for Loading Defaults. As a result, there can be some events that are specifically targeted to selected Institutions. That way, when the "Load Defaults" button is clicked in the IRB area, only those Default Events that are tagged for the working Institution are listed. By default, all existing ORC Events that were set to a Default, have all Institutions available for Access.
IDEA:
1. See CREDIT items: 1, 2, 4, 10, 11, 12, 13, 14
IRBANA:
1. See CREDIT items: 10, 13
2. In the Report "Meeting Documents for Review" where staff download and review documents, there are 2 new links on the page for each document. The first is in the new "Comments" area for each document where there is a link to "view\hide" the Comments. The second is the same functionality for the list of staff who have downloaded the document. Hiding these data elements can reduce the size of the overall page which can be helpful when printing.
3. When uploading a document into an IRB Log, there is now a checkbox that allows it to be tagged as a "New Document for Review".
BIOSPEC:
1. See CREDIT items: 4, 10, 12, 13, 14
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12/08/2012
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PLEASE, encourage your logon staff to use the "MY ACCOUNT" button in the upper right of the Main Menu to add their Email Address into the System. This helps us communicate directly with staff if they have a problem inside of a DDOTS System.
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CREDIT:
1. The Report "Protocol Treatment Report" now allows filtering per Protocol or Sponsor.
2. There is a new ID field in Prestudy Screening Workups: "NCCCP Log ID". To enable this new field, File Ops > System > System Variable Default Values > Prestudy > NCCCP Log ID > Enable.
3. The Patient Audit History Page now allows for Attaching\Uploading Documents to the Audit Logs. The documents are associated with an Audit entry, and Document Storage is under the Patient Photo\Demographic page, Mini-Menu > Patient Documents. It is from this page that the Documents can be Deleted.
4. When Collecting Financial Milestones, the value for Screen Failures can now be changed on the fly.
5. There are 2 new Patient Protocol Fields that can be Enabled (File Ops > System > System Variable Default Values > Patient\Study) (by default they are Disabled):
Show Patient Study OFF TREATMENT Reason "Note Box"
Show Patient Study OFF TREATMENT Reason "Note Box"
When Enabled, next to the patient Off Treatment and\or Off Study Dates is a simple text box named "Details". This allows for more explanation about the reason for Off Treatment and Off Study. While the box appears small, it can manage up to 1000 characters.
The result of this is that the Protocol Follow-up Sheets can echo those typed Details. For this to display, the Off Study and Off Treatment Dates need to be included in the patient information table at the bottom of the Follow-up Sheets. This can be accomplished via File Ops > IRB > Edit IRB Meeting Environment Defaults > #34.
6. There is a new feature available via File Ops > System > System Variable Default Values > Auto-Generate Patient Protocol ID
By default it is Disabled. There are 3 options for this feature. A) Disabled. B) Enable Globally. C) Enable Globally, allow Protocol Override. A & B are self explained, they either generate a unique number for every new patient on every protocol, or not. Option C is more detailed. If this is selected, each Protocol (on the Protocol Data Page) will display new code to allow the specific Protocol to manage the counter for generating new IDs.
The rules are pretty straight forward. If the System setting has the Counter set to 0, it does nothing. If the Protocol has the Counter set to 0, it does nothing. However, let's just say that we would like a specific protocol to generate unique numbers for patients on that study. Set the counter to the first ID to load, let's just use "1". The first patient will get that number, and the counter on the protocol will roll to "2" in prep for the next patient.
The system does allow for User Override. Clicking that link when Adding a Patient to a Protocol, opens the text box back up for manual typing.
7. Each IRB Document could be stored in a Folder. However, if a Submitter for CREDIT put it into a Folder, and the IRB Moved the document to a different folder, the CREDIT staff would then find the document had been moved. So they might move it back, causing the IRBANA team the same problem. And so went the tug-of-war. Not anymore. Now, each institution can have the IRB Document stored in the Folder of their choice, without disrupting the other..
IDEA:
1. See CREDIT items: 1
2. When Loading in Patient Returns, the Expiration Date now pre-populates in the Memo Box to help save time looking up that date.
3. On the Patient Returns Page, there is a new link to "Show Memos" or "Hide Memos", which toggles the open\close display of the Memo Field.
IRBANA:
1. See CREDIT items: 7
2. If using the IRB Meeting Attendance Report to record the staff who participated in the meeting, those staff are then filtered for voting in the Meeting Activity Recorder. For this system to be enabled, File Ops > System > System Variable Default Values > Filter IRB Member Voting Per Meeting Attendance must be Enabled. By default, it is Disabled.
BIOSPEC:
1. See CREDIT items:
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11/24/2012
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PLEASE, encourage your logon staff to use the "MY ACCOUNT" button in the upper right of the Main Menu to add their Email Address into the System. This helps us communicate directly with staff if they have a problem inside of a DDOTS System.
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CREDIT:
1. The IRB Meeting Submission Lookup report is now filtered by Department.
2. ICD-10 codes are now available in File Ops for Add\Edit\Delete.
3. Prestudy Patient Workups can now have "Outcome Reasons" added to the workup. They are also available on the Prestudy Report.
4. The Prestudy Patient Data Page now displays the Living Age of the Patient as of Today (if Birth Date is entered), or Age at Death (if both Birth & Death Dates are entered).
5. The Patient Data Management Log now has the ability to "Complete" events directly on the Log Display Page. This reduces the need to "Edit" the entry to Complete the Submission Log.
6. There is a new Financial Report: Projected Patient Milestones, both Invoicable and\or Payable.
7. The Patient Master Schedule Report now allows for Filtering Financials based on an amount that is Invoicable vs. Payable vs. Both. There is also a new column to list the Financial Payables.
8. The Patient Data Management Report now allows for multiple department selection and export to Excel.
9. The Invoice Aging Report now allows for the selection of "Sponsor Affiliation" (NCI, Comm, Internal, etc...)
10. When giving Access to Component Institutions, the Status Entries that are set also carry over the IRB ID and the Milestone Collection List. This eliminates the need for staff to update each institution with the study IRB ID and "Disable Financials".
11. There is a "Mimic Team" button on the Protocol Research Team page. It allows staff listed for the current institution to be copied over to other institutions that have Access to the Study.
12. The "IRB Submission Received Date" can now be Enabled\Disabled. Both CREDIT and IRBANA must be installed in the Combined system for this feature to exist.
13. The On\Off Study Report can now be Ordered by the "Patient Alternate ID" (which can be enabled in File Ops > System >) and can also be re-titled there.
14. There is a new Module for Patient Protocols. It is found in the Mini-Menu on the Patient Study Page "Concomitant Meds Log". The log allows for add\edit\delete con meds for the patient.
15. Prestudy Screen "Contact Source" can now be made "Required". This option removes the "Unknown" selection if Enabled. File Ops > System > System Variable Default Values > Prestudy > (last entry).
16. The Report of "Staff by Components" now allows for Department Filtering.
IDEA:
1. See CREDIT items: 14, 16
IRBANA:
1. See CREDIT items: 1, 16
2. New Documents for Review Report can now be filtered per assigned Reviewer or not filtered (default). If IRB Events are assigned a Primary or Secondary Reviewer in the IRB Logs, that is the filter setting available in the Report. So, if Dr. Smith is set to Primary Reviewer for 4 of the 10 Revisions, the report can be filtered when Dr. Smith logs in to just show the 4 events assigned to Dr. Smith.
3. The Financial Module is now available in IRBANA.
BIOSPEC:
1. See CREDIT items:
2. Patient Specimen IDs can now be automatically generated. File Ops > System > BIOSPEC. The option is to Enable this feature. Then a Prefix can be set "BR", then a Code value "2012" or dynamic date "yyyy-mm-dd" (which will populate the current date), then a Counter Number that will be incremented as the numbers get assigned to patients "55" (which will then become 56 when a patient is assigned the 55 value), finally a Suffix "SJ" can be added.
Example:
BR-yyyy-mm-dd-55-SJ
or
BR-2012-55
or
BR-12-55
etc...
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10/20/2012
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CREDIT:
1. The Patient Protocol Consent Date has a new "Consent Waived" link that loads the date "1/1/1900" for the date.
2. The Institution Calendar is now designed to filter per Department. If the logon user has rights to various (or a single) departments, those department calendars can now be shown inclusive or individual. There has always been the ability to filter per Institution. This option allows for each department to keep their own calendar on-line.
3. When Editing a Check Allocation, the Check Number can now be changed. There is an image of a small pencil that can be clicked on (which is next to the Check Number), to begin the Edit\Save feature.
4. There is a new report for "Patient Requisitions".
5. If Staff Licenses are Archived, no email notifications are sent for those licenses.
6. Staff Licenses now have a "License Date" that is an optional date field.
7. When archiving a Patient, there is now an option to archive the patient protocol(s) at the same tim.
IDEA:
1. See CREDIT items: 1, 2, 5, 6, 7
IRBANA:
1. See CREDIT items: 2, 3, 5, 6
2. New Macros for Letter Generator:
@EventDate = IRB Action Date
@ReviewMonths = Number of Months Approved
@ExpireDate = Review Expire Date
@IRBPISal = PI Salutation (Dr.)
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07/21/2012
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PLEASE, encourage your logon staff to use the "MY ACCOUNT" button in the upper right of the Main Menu to add their Email Address into the System. This helps us communicate directly with staff if they have a problem inside of a DDOTS System.
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CREDIT:
1. The Current Status Report now includes the columns for Financials:
Lab Information System Number
Study Account Number
2. There is a new document in the On-Line HELP module. "Financial RFPs for Component Milestones". This document details how to create Requests for Payment to Component Sites per Accruals, or other Payables related to a Date Range. It is a 2 step process. First it creates the RFPs, then the Second Report details the payments due to each Component Site. For institutions that are cutting checks to components for Accruals or other Patient Milestones, this can save hours of work.
3.All Canadian Provinces are now available for selection wherever there is a dropdown box for "State\Province":
ON-CAN Ontario, CAN
AB-CAN Alberta, CAN
BC-CAN British Columbia, CAN
MB-CAN Manitoba, CAN
NB-CAN New Brunswick, CAN
NL-CAN Newfoundland and Labrador, CAN
NT-CAN Northwest Territories, CAN
NS-CAN Nova Scotia, CAN
NU-CAN Nunavut, CAN
PE-CAN Prince Edward Island, CAN
QC-CAN Quebec, CAN
QC-CAN Saskatchewan, CAN
YT-CAN Yukon, CAN
4. When Archiving a Protocol, there are now an unlimited number of "Locations" available. This due to one study may run over the old 2 Location Limit.
IDEA:
1. See CREDIT items: 3, 4
IRBANA:
1. See CREDIT items: 3, 4
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07/07/2012
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CREDIT:
1. The loading of the Protocol Invoice Page has been improved by a magnitude 100. Pages with over 20 invoices were loading in a little over 1 minute. They now load in a matter of seconds.
2. When adding a new manual event, the event can be checked as "COMPLETED" right there in the selection mode. There is no need to THEN go to the checkoff page to complete the event, saving time.
3. There is an updated version of the "CREDIT Introductory Guide: Financials" available via the HELP Icon, On-Line Documents.
IDEA:
1. See CREDIT items:
2. When changing the Hospital of Registration, the Pharmacy Dropdown box reloads with the Pharmacies for the newly selected Hospital. This is ONLY in ADD Mode.
IRBANA:
1. See CREDIT items:
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06/23/2012
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CREDIT:
1. There is a new Budget Billing Grid that is available on the Protocol Schema Development Page. When Events are added to the Schema (Rainbow) Page, they can be tagged as: N/A, SOC, Research, Unknown. Then when those events are scheduled on the Rainbow Page, that creates the new Billing Compliance Schedule (new button) that shows which events are S and which events are R. The page also totals the charges expected to be paid by the Sponsor or Insurance.
Finally, these values are echoed in patient calendars when the calendar is first constructed. Staff checking off events can change the defaults set per the Schema if needed. And, upon saving, CREDIT looks into the Registration Hospital to see who the Billing Staff are. It pulls those staff, flags them for sending emails to notify the Billing Department of the patient events, both SOC, Research, and Unknown events are included in the notice.
2. If the "Protocol Type" field is Enabled, that field is now available in the Financial Report: Invoice Generator
3. When a patient is entered into Prestudy, allow email notification that also includes the ability to put BODY info into the email. "Sally, patient may qualify for your study."
IDEA:
1. See CREDIT items:
2. When the Patient Dispense Page loads, there is a new line of information in the upper left of the Inventory Selection. There is a Look-Ahead to locate the number of additional Dispenses the patient has for the specific drug. As an example: " (40 More Dispenses Found) ". If the current dispense is the very last dispense in the Patient Calendar, the message is: "(NO More Dispenses Found)". This should alert staff that IDEA does not have any more calendar for the patient for Dispenses. If the patient requires additional dispenses, staff should use this warning to alert them to add Manual Dispense Events into the patient calendar. Failing to do so could well result in a drug shortage for the patient. This is because the IDEA Look-Ahead for Inventory would not include this patient in the evaluation because of the lack of Calendar Events for Dispensing.
IRBANA:
1. See CREDIT items:
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06/09/2012
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CREDIT:
1. The Popup Collect Milestones Invoicing now has Navigation Links for fast paging.
2. The On\Off Study Report now allows for Sorting by Race or Ethnic Category.
3. The Active Research Team Report now allows for a simple (summary) listing of staff associated with studies of selected Status.
4. There is a new set of fields in the Protocol Data Page: Patient Min. Age and Patient Max. Age. For this to be active, it needs to be Enabled via File Ops > System > System Variable Default Values > Protocols > " Show Patient Minimum\Maximum Age on Protocol Data Page" > Enable. This feature is then used to evaluate protocol availability for patient attachment both in Prestudy and Patients.
5. The Time-Task Recorder now allows for selection of Sponsor to log time.
6. When adding a patient to a protocol, the Patient Protocol ID (supplied by the sponsor) is evaluated at each keystroke to determine if the entered value is Unique (to that study) or NOT Unique (to that study).
7. When the Patient Check-off Calendar (All Events) loads, it also shows events that are already Completed. There is a new System Variable that will default the calendar check-off display to "Hide Completed Events", with a button to "Show Completed Events". By default, this File Ops > System > System Variable Default Values > Patient\Study > Hide Patient Checkoff Completed Events is set to DISABLE. We HIGHLY recommend that this feature be Enabled as it will save staff hours of time over the year. Basically, when the page loads all of the historical data takes time to load. And upon Save, all of those Completed Events get re-processed again and again and again, every time the page is saved. As the Completed Events get to be more and more, additional time is saved by hiding those events.
While we would like to have set this feature to ENABLE, we thought it better to not surprise the user when the Check-off Page Loads and Completed Events "appear" as "gone". Please ask your CREDIT Admin to Enable this important feature!
8. New Report: Meeting Ranged Activity Summary The Report allows for IRB Date Ranging, pulling protocols that had activity within that date range, then displaying all IRB Log events found for each protocol.
9. When creating a Request for Payment (RFP), if the event is something that the Sponsor Pays for, and the Sponsor has already paid, that paid amount will be displayed in the data line as "Received: $xxx.xx". This allows the user to quickly review (and remove) elements in the RFP that should not be paid out due to the fact that the Sponsor has not yet paid Research for the Event.
10. When an Invoice is created, and it contains an IRB Revision, the "Revision ID" is now included in the line item.
11. The Hospital Calendar now has a Document Upload Feature. This means you can upload a documents for specific calendar events.
IDEA:
1. See CREDIT items: 2, 3, 4, 6, 7, 11
2. There is a new System setting that allows for displaying ALL patients from ALL Hospitals (staff authority filtered) for selection of Dispense. The issue here is when patients "hop" from one clinic to another on a weekly basis for treatment. Prior to this option, the patient would need to have their Registration Hospital changed in order to reset where the patient would be going for treatment on that given day. Then, for the next treatment, yet another change would be required. Now, with File Ops > System > System Variable Default Values > Patient\Protocol > When Dispensing Drug, allow Patients to be Treated in All Hospital\Pharmacies Enabled, a new button will appear at the Patient Listing for Dispense to "Show All Patients". When clicked, the patient selection box reloads showing all patients from all registering hospitals that the staff has authority to see. Then the patient can be selected, and on the Dispense Page, a simple click re-assigns the pharmacy of dispense to the current pharmacy.
IRBANA:
1. See CREDIT items: 3, 8, 11
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03/31/2012
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CREDIT:
1. Several Fields in the Deviation Log can now be Enabled\Disabled
2. Prestudy Patient Workups now include an "Education Date:"
3. When we upload a new document into the Library, we can Email Notify staff. Now, when we Edit a Document, AND those who were already notified, those staff are already populated in the Selection Box to be Re-Notified.
4. When Recording via Patient Consent Form Log, upon Saving, there is a new button to "Return to Edit Form" that allows for continuing to log Consent entries.
IDEA:
1. See CREDIT items:
IRBANA:
1. See CREDIT items: 1, 3
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03/17/2012
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CREDIT:
1. The Invoice Module allows Document Upload per each Invoice. Now, if that Invoice includes Direct Costs that have Documents Uploaded, those Documents now appear along with the Invoice Documents in the popup window.
2. The Protocols Per Department Report now allows for selecting multiple departments.
3. There is a new File Operation that allows for creating "Hospital\Department" connections. This feature is the beginning of "Default Values" that can be applied to the Hosp\Dept combinations. This first of which is a "Default IRB Document Library Note". The first step is to create the connection in "File Ops > IRB > Add Hospital\Department Connection". Once a Hospital and Department have been paired, the connection can be Edited to allow for this first Library Note Default value to be inserted. The concept on this default, is that standard language can be typed into the "Connection Default" page. Then, in the IRB Library, when uploading a new document, there will be a "Load Default Note" button. Clicking the button populates the Note box with the default value typed into the "Connection" for that Hospital and that Protocol Department.
4. When running the IRB Meeting Recorder, each entry can now have New Consent flagged as well as Re-Consent Patients Flagged. Previously, these settings were only available when Editing and IRB Submission directly within a Protocol.
5. The Protocol Financial Invoices Page now allows for Document Uploading.
6. When generating an Invoice, the top Payee and Remit To may have some fields with no data. In that case, the title to those fields is no longer displayed.
7. Financial Requests For Payment can now have the Specific RFP Date set during Adding or Editing and RFP.
IDEA:
1. See CREDIT items: 5, 6, 7
IRBANA:
1. See CREDIT items: 3, 4, 5, 6, 7
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03/03/2012
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NOTICE: We are once again planning a Summer Training Session in Ann Arbor, Michigan for CREDIT.
Please copy and paste this link into a browser to download the Agenda and Registration Form.
https://www.ddotscredit.com/DDOTSHelp/DocumentsPage01.cfm
The top 2 Documents in the web page are the Agenda and the Registration Form.
Complete the Registration Form and mail to DDOTS, or Scan & Attach for reply to this email. You *CAN* reply to this email, although the "FROM" indicates you cannot. Remember, May 31 is the DDOTS Cutoff Date for getting Registered. Registration beyond that date (space available) will be $400 per day per attendee.
Meeting Dates are July 9 & 10, 2012.
The Hotel for the meeting will be "Kensington Court", Ann Arbor, MI.
Room Rates for the meeting are $98 +tax per night.
Rates are available until Monday, June 25, 2012.
Please make your own hotel reservations.
Attendees need to bring a laptop with WiFi Wireless capable.
Lunch will be provided each day, and an "all day coffee break" is also provided.
Cost for each attendee is $300 per day for Pre-Registration before June 1, 2012.
Registration beyond that date (space available) will be $400 per day per attendee.
As of today, we have about 10 staff indicating interest in the 2 day sessions (the classes are limited to 20 attendees per day).
You CAN REPLY to this email and Barbara will receive it.
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PLEASE, encourage your logon staff to use the "MY ACCOUNT" button in the upper right of the Main Menu to add their Email Address into the System. This helps us communicate directly with staff if they have a problem inside of a DDOTS System.
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CREDIT:
1. The Financial "Accrual" page now has a field to load the "Payable" for Regulatory Logs. When there is a $ value in that field, the Request For Payment (RFP) Module will associate that default value with Regulatory Log Entries when "Collecting Payable Milestones". This eliminates the need to manually create a "Direct Payable" when there is an IRB Approval for a submission that has to be Paid out of the Project.
2. When designing a Protocol Segment, the VIEW SEGMENT button is replaced with "Processing..... please wait". This eliminates the double clicking on the button which restarted the loading of the page.
3. There is a new System Setting that allows for turning off the "Eligibility" box on the Protocol Page. This is mainly a function of IDEA.
4. There is a new System Setting that allows for Alerting the User when patient status is changed to selected status. File Ops > System > System Variable Default Values > Patient\Study > Show Alert when Patient Status is Changed : and the additional text box that will contain the Alert Message: Alert Message to Display on Patient Status Change
5. The Bulk Screening Module now allows for loading multiple, duplicate screenings at one time.
6. The Bulk Screener Module now allows for selection of Registering Institution and Study Coordinator
IDEA:
1. See CREDIT items:
2. When Auto-Receive a drug, if there is no Package Design, there is a link on the Receive page to "Go There" to Add\Edit Packages.
3. When Pre-Populating Drugs, when the Button is clicked to Save the entry, the button is replaced with "Processing..... please wait". This eliminates the double clicking on the button which created 2 entries.
IRBANA:
1. See CREDIT items:
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02/18/2012
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CREDIT
1. The Pre-Study Listing Report now allows for Sorting by Hospital, and includes Summary Totals capability including Pie Chart. This same report also will summarize Patient Investigators including Pie Chart.
2. There is a new Patient Billing Compliance Processing module. It all begins with File Operations, and Edit Agents, Edit Labs, Edit Activities, Edit Financials. For each item "Mammogram", there is a new checkbox for "Send to Billing". For Labs, as an example, use the SHOW EXISTING FILE link such that all of the checkboxes are available on one page. The Next Step is to go into one of the Studies that you want this new feature to work on. The upper right corner of the Protocol Data Page has a check box for: "Enable Patient Events to be 'Sent to Billing' [ ]". Checking that box and saving, enables patient calendars to display the Radio Buttons described below. If the box remains Unchecked, no Radio Buttons will appear on the Patient Calendar Check-off page.
Checking the box flags Patient Calendars so when the Completed checkbox is shown, there are 3 new Radio Button Options to select:
UNKNOWN
SOC
RESEARCH
By Completing the event (checkbox) and selecting the Billing Category, the event will appear in a new report: Billing Compliance Processing. The report allows the Billing Specialist to set Date Ranges, Departments, and "Unprocessed Only", "Already Processed", or "Both". There are a variety of Columns to Include available.
When the report is generated, each patient calendar event can then be managed per "Compliance Date", "SOC vs. Research", "Notes", and a checkbox to denote the event is ready for Billing. An Email Module is included such that Completed Billing Entries will have that data sent (Outlook) to selected staff. All of the details of each processed event are included in the email.
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Entry: 1.
Patient: Burke,Barbara (3456789)
Study: B-43 (NSABP)
Research Investigator: Stella, Philip J
Event: 02/02/2012 - Mammogram
Notes: Testing
Research Staff: Burke, Stephen W
Billing Processed: 02/06/2012
Billing Note: wwwwww
Billing Category: Standard of Care
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Default Selected Email Staff can be set in File Ops > System > Edit Staff Notifications > (last column to the right)
Email Patient
Billing
Processing
By checking the box for selected staff, those names will be default selected in the Email Notificaion Selection Module for the report.
3. There are now more "Staff Access" points in the Protocol Data Mini-Menu. Each element is now managed by Staff Access. So, if Staff are not getting into areas that they have authority, please check their Staff Profile Access check boxes and update as needed.
4. The Patient Calendar now allows for Exporting to Excel OR Exporting to Word, multiple months, each month on a single page.
5. When Merging a Document from the Document Processor, the Single Merge now allows for exporting the output to a TEXT file.
IDEA:
1. See CREDIT items: 3, 4
IRBANA:
1. See CREDIT items: 3
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01/28/2012
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CREDIT
1. The Time-Task Recorder captures staff time per study & task. When creating a Request For Payment in the Financial Module for the study, traditionally the staff values were defaulted to what ever staff POSITION they were assigned. So Admin staff all had the same rate, Doctors all had the same rate, etc. Now, however, there is a new Staff Field in each staff profile, directly under where the Staff Position is assigned "FTE Rate $ ______". It is this new field that computes the total amount to be paid to the staff from the Task Recorder.
2. The HELP, and MAIL Navigation Buttons at the top of the system now allow for the popup windows to be resized.
3. The General Report: View Patients by Staff, now includes a new Column to Include: Last Patient Event Completed Date.
4. The Report "General > Active Research Team Staff" now includes the ability to filter by Staff Capability Participation. That field is also a new Column to Include.
5. There are 5 new Sponsor Macros available for Merging with Documents:
@SponsorStreet
@SponsorCity
@SponsorState
@SponsorZipcode
@SponsorPhone
6. The Protocol Build Module, Add Activities Page, now allows for Multi-Select of Activities. This replaces the single dropdown box.
7. The Protocol Treatment Report now searches the Arm Notes for the existence of the selected drugs.
8. User Defined Field "Answers" can now be sort ordered.
9. The Regulatory Financials now allows for "Payables". When a study is financially enabled, the "Accruals" page allowed for setting the Invoice Amount of all regulatory events. It now allows for "Payables" as well. So, if an IRB get funds for reviewing regulatory elements, those payables can now be managed in the system. Further, there is a "BALANCE" value in the toolbar that reflects the cash on hand for the study.
IDEA:
1. See CREDIT items: 2, 3, 4, 5, 7, 8
2. When on the Dispense Page, if the Look Ahead has been Deactivated, a new link appears "Patient File Cabinet". The link navigates to the Patient Search Engine where patients can be added and attached to a protocol. Once that is done, the Event Focus Page Mini-Menu will have a new option: "Dispense Pharmacy". Using that option navigates to the Dispense page for the study and pharmacy.
IRBANA:
1. See CREDIT items: 2, 4, 5, 8
2. For installations with both CREDIT and IRBANA, the IRB Submissions can now be Locked by either system. This is dependant on the settings for each IRB Action. So an action of "Held by CREDIT" can be locked by CREDIT, and not available to the IRBANA team. Then, perhaps the CREDIT Team sets the Action to "Sent to IRB". Once saved, CREDIT can no longer manage that submission, rather the IRB then has control, and will remain in control unless they set the submission to some Action that Unlocks it for CREDIT. So, the IRB could reject the submission, and set the action back to "Held by CREDIT", or "Returned from IRB", or "Approved". This feature allows for "handoff" or "ownership" of each submission.
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01/14/2012
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CREDIT:
1. Prestudy Patient Outcomes can now be set to "Inactive" vs. "Active". File Ops > Pre-Study > Edit Prestudy Patient Outcome. When set to Inactive, the outcome is not available for selecting in the prestudy workup module.
2. When uploading Documents into the Regulatory ORC Module, the system now captures the Staff who were Notified of the Upload.
3. Deviations now have an "OHRP Notification Date" field. The Protocol Deviation Event Report now includes this new date.
4. If Invoice Documents have been uploaded and associated with IRB Log entries, the Log entry has always displayed the Invoice ID, but now that ID is hot linked to popup the Invoice Documents.
5. There is a new System Mail Notification available: Prestudy Consent. To set staff to be notified, File Ops > System > Staff Notifications. The first column of check boxes sets the new notices.
6. The Protocol Status Notes are now inside of the Editor so they can be formatted similarly to the Eligibility.
7. In the Patient Calendar Page, when staff make a note for a given date or dates, the Staff Name, Date, and Time of the entry are captured. There is a "Mouse-Over" for each event that will show the Staff, Date & Time the entry was made.
8. The Link Patients & Protocols Report has a new Export File option on the Output Page. IF a Single Protocol is selected, and the Export Merge File is named, at the bottom of the output report page is a quick link to Review the Export File. The link opens up the Documents (Forms) folders so the user can select the letter to merge. Once the letters have been created, they can be directly printed from the review window.
IDEA:
1. See CREDIT items: 6, 7, 8
IRBANA:
1. See CREDIT items: 3, 6
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12/31/2011
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CREDIT:
1. The Patient Protocol ID (Sponsor Assigned) now displays next to the Patient Name in the Patient Toolbox (below the Mini-Menu) on the Patient Calendar Pages.
2. There is a new Patient Macro: @FullStreet. It will merge Address1 and Address2 of the patient demographic page.
3. There is a report that lists the total milestone dollars per patient. The reason for the request is because often sponsors send reports listed by patient that gives the total milestone amounts to date. You can now compare these reports with Credit.
Example:
Study Name: Astro 2302 Reporting Period: October 1, 2009 â?? October 28, 2011
Pt: SH00067 Total # milestones completed-7 Total Dollars-$745.00
Pt: SH00068 Total # milestones completed-5 Total Dollars-$550.00
IDEA:
1. See CREDIT items: 1
IRBANA:
1. See CREDIT items:
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12/10/2011
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NCI CCOP Reporting: MA.32-QOL = 0.50 CC Credits. If you have not done so already, you will need to make a separate Arm Q for this credit. The Report Name should be "NCIC-MA.32-QOL". Register patients to this Arm who qualify for the 0.50 CC.
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NOTICE: We are once again planning a Summer Training Session in Ann Arbor, Michigan for CREDIT.
We have not yet set an agenda as we need to determine what topics to cover and who might attend.
So, you CAN REPLY to this email and Barbara will get it.
Let her know if you are interested in a training session, and what topics you would like covered.
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CREDIT:
1. There is a new Report: IRB > Activity Summary (By Protocol Type) that will allow for polling the data to determine the number of submissions per "Protocol Type", Review Type, and Action.
2. For the Protocol Research Teams, there is a new set of fields: "Financial Disclosure Amount" and "Financial Disclosure Date". These new data elements are also now included in the report: General > Staff Involvements. The report can be filtered per a Minimum Disclosure Amount. 0 (zero) disables filtering by Disclosure Amount. So, if a value of $"5000" is part of the filtration, only staff with Protocol Disclosures greater than or equal to $5000 are included in the output.
3. For Patient Deviations and Adverse Event entry, the checkbox for "Create IRB Entry" can now be defaulted to "Checked". This is enabled via: File Ops > System > System Variable Default Values > Patient/Study at the bottom of that section:
Default-Check "Create IRB Entry" for Patient Deviation
Default-Check "Create IRB Entry" for Patient Adverse Event
By default, these settings are "Disabled"
4. When IRB Logs require patient re-consenting, we have been using either the action of Approved or Continuing. We have now added Acknowledged to that trigger.
5. The IRB Report for First Review and Last Review now allow filtering per Sponsor Affiliation.
6. When Editing a protocol Adverse Event, if that event has multiple "other protocols" associated with it, listed in the top left of the popup window, if you check the boxes to "also update", and then attach a document for uploading, the attachment will be associated with all of the other checked studies. Upload once that letter of approval, and it will be seen in all of the other protocol IRB Document Libraries. *Note* if you Un-attach the document in Edit mode, for safety purposes, it *only* removes the letter from the currently edited entry. All other entries where the document was associated will still have that attachment.
7. User Defined Fields (UDF) are now available for "Order Table By:" in the Report On\Off Study.
8. The Time\Task Recorder is filtered by Protocol Status. Until now, all Status were selected. Now there is a System variable that allows for default status selection, which filters studies immediately. File Ops > System > System Variable Defaults > Financials > Default Time\Task Protocol Status List
IDEA:
1. See CREDIT items: 2
2. There is a link on the Patient Returns DARF that allows for popping up a Patient Specific DARF.
IRBANA:
1. See CREDIT items: 1, 2, 5, 6
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11/26/2011
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CREDIT
1. There is a new value in the Financial Module to allow for "Capitation Cost per Accrual (Estimated)". This value is calculated in when doing an Analysis of the Study Financials. We already had the "Income per Accrual", now we are adding the "Cost per Accrual".
2. There is also a new value for "Indirect Percent of Costs per Accrual" which calculates from the value in item #1 on this updater.
3. There can now be an Indirect Cost % set for Protocol FTEs. The setting is on the Financial Accruals page.
4. For Budget Considerations, the Financial Accruals Page now allows for Estimating the number of SAEs per year, and the number of years for Analysis.
5. The Patient Search Engine now includes searching for the Medical or Follow-up Location.
6. CREDIT now has the latest NCI Data File for CCOP Progress Report Crediting Submission.
7. The Cash Receipts Journal Report now allows for the inclusion of the Protocol when the "Simple Check Listing" option is selected.
8. There is a new Macro for the Patient Apt. or Suite: @Street2
9. When a patient Protocol Page loads, the Aux. Doctors are filtered per that institution. Now, there is a button to un-filter the list such that all Doctors will appear in the dropdown boxes.
10. The Master Schedule now allows for selecting Multiple Sponsors on the Request Page.
11. Email Notifications from the System have always been filtered per Hospital Access per the Staff Profile Pages. Now, the filtering has been extended to Departments. This means only Cardio staff will get Expiring License Notices for those in that department. Of course, staff can have multiple department access, which means they will get notices from each department within CREDIT.
12. We now allow the Protocol Status Report to be sorted by Next Review Date.
13. Email Notifications per Staff License Expiring now includes CREDIT Staff to contact per those expirations. As an example, if Dr. Smith gets an email notifying him that his 1572 has expired, the email will contain the names and contact information of the CREDIT Team.
IDEA:
1. See CREDIT items: 5
2. The Dispense Report now allows for a Summary. The Summary breaks down dispenses by Sponsor, Protocol, and Pharmacy.
IRBANA:
1. See CREDIT items:
2. Right now, in the IRB Document Library, documents can be flagged as "New Documents for Review". That forces them to show up in a Report that IRB Members go to for reviewing those documents per protocol.
When the meeting is all done, staff have to run that report and hand check to MOVE (or remove the NewDocumentFlag) so the document is no longer tagged, and will no longer show up as a New Document.
There is now an IRB Environment variable (File Ops > IRB > Edit IRB Meeting Variable Defaults > [last item] by default it is disabled) that can be the trigger for auto moving (if there are any) starting the day after the meeting occurs. This fires at first person logon every day after meeting(s). Future meeting documents will not be moved.
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10/29/2011
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CREDIT
1. There is a new system that allows for each Master Calendar Event (Rainbow Page) to have a "Staff Task" and default Time associated. For this feature to be enabled, it must be set in File Ops > System > System Variable Defaults > Financials > Capture Calendar Event Durations.
Once set, when a patient calendar is created, under the checkbox for Completed will be the Task and an HH:MM set of boxes that are filled with the default values set in the Rainbow Page. The Default Hour and Minute values can be changed on the Check-off page. When the page is Saved, CREDIT automatically adds the Task to the Time Task Recorder. That task is then fed into the Financials Module as "Actual" FTEs for Budget considerations.
3. There is a new "IRB Action Date" available for Enabling (via File Ops > System > System Variable Default Values) for the IRB Deviation Log page.
4. The Time Task Recorder now has a "Save and Reset" button that, after saving, sets all selections back to "like new". The Save and Continue button retains the current selections after the save.
5. The Patient Mailing Labels now includes a new Column: Birth date. Use the column to capture the birth date for staff in a given Month. Do not use the column for creating actual Mailing Labels.
6. When the Protocol Data Page is printed, the new Eligibility Editor does not print, but the contents of the Editor (Eligibility) does print. This provides a cleaner page when printed.
7. The Financial Cash Receipts Journal has been re-written and the Grand Totals on the bottom have been relabeled for clarity.
IDEA:
1. See CREDIT items: 5, 6
IRBANA:
1. See CREDIT items: 3, 6
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10/15/2011
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CREDIT
1. The "Time Task Recorder" now allows for filtering per study status. A clickable link expands available status selections. If you only want OPEN studies, uncheck the other status and the Protocol Dropdown Box reloads with each Unchecking, until finally there are only OPEN studies showing.
2. There is a new "Current Assent Date" that can be enabled on the Protocol Data Page. To enable the date, File Ops > System > System Variable Default Values > Show Current Assent Date on Protocol Data Page > Enable > Save. The Current Assent Date will be located directly under the Current Consent Date (if this date is enabled) on the Protocol Data Page.
3. The Time Task Recorder now allows the existing Log to be filtered per staff member.
4. For NCI CCOPS, reporting table modifications: Table 6A & 6B were revised by the NCI in April of this year. Basically, they were removing Table 6C and condensing the data into Table 6A. The new report is now compliant with the NCI change.
5. The Protocol Treatment Report now allows filtering per IRB of Record *if* that feature is turned on for protocols.
6. Financial Invoice Editing now allows for changing the Invoice Date.
IDEA:
1. See CREDIT items: 5
IRBANA:
1. See CREDIT items:
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10/01/2011
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CREDIT
1. User Defined Fields (File Ops > System) now allow for User Defined Macros for data importing into Documents.
2. The Financial Invoice\Statement Generator now allows for the Statement to be ALL INVOICES, or simply Invoices with outstanding balances.
3. If the Time\Task Recorder is opened in the Patient Protocol Page, the default selections will be the specific Patient and specific Protocol.
4. There is a new Financial Report: Revenue Flow Graph. It allows for date spanning and produces a bar graph of income over time.
IDEA:
1. See CREDIT items: 1
IRBANA:
1. See CREDIT items: 1
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09/17/2011
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CREDIT
1. New Report: IRB > Institutional Demographic Report
2. Protocol Eligibility can now be formatted in the Edit Protocol data page. The Document Editor loads to facilitate fonts, sizes, colors, bold, numbering, etc...
3. New Macros for the IRB Revision Modification Form:
@LogonStaffEmail
@LogonStaffPhone
@LogonStaffFax
@NurseEmail
@NursePhone
@NurseFax
@CoordinatorEmail
@CoordinatorPhone
@CoordinatorFax
IDEA:
1. See CREDIT items: 1, 2
IRBANA:
1. See CREDIT items: 1, 2, 3
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09/03/2011
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NOTICE: If you rely on the DDOTS Library for your protocol designs, please check it regularly for amendments that your IRB has approved. You can compare the version Date\Time stamp of the study design in the Library with your installed design for any given protocol. The DDOTS Version is simply a date stamp of when the study was last updated. So, the number: 20100212132245 means: yyyymmddhhmmss or in this case, February 12, 2010 at 1:22 PM and 45 Seconds.
CREDIT
1. The Master Schedule Report now allows filtering events per: "Only Completed Events and Unchecked-off events".
2. Staff Affiliations are now part of the Staff Information Report.
IDEA:
1. See CREDIT items: 1, 2
2. There is a new System Variable that toggles the Drug Transfer Acknowledgment notice in DARs to show or not show.
IRBANA:
1. See CREDIT items: 2
2. There is a new option for outputting merged Documents: Email. The system allows for loading email bodies with the merged message, and lets the user load in Subject, and addresses. It also allows for creating a PDF of the email that can be loaded automatically into the IRB Documents Library per each study.
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08/20/2011
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CREDIT
1. In Prestudy, Chart Location is now carried over with the Patient Activation to the Patient File Cabinet.
2. The Financial Time Task Recorder has been re-organized to allow the Save button to be shown without resizing the window.
3. The Patient Calendar now allows for multiple date entries, much like the Hospital Calendar. The Note dates made on the Patient Calendar can also be displayed on other Patient Calendars (check-off, Master Schedule Report, etc...)
4. Clinical Trial Registry Program (CTRP) ID is added to the protocol data page. This new field is yet another ID that is being used to identify studies. It can be enabled via the System settings.
5. Right now the On Study Date can be earlier than the Original Consent Date. We now error check for that, as it is not allowed.
IDEA:
1. See CREDIT items: 3, 4, 5
2. There is now an "Acknowledgment" notification when entering a protocol via a receiving pharmacy for Transports. The notification will remain on the DARF Menu page until the Acknowledgment is completed by the user.
IRBANA:
1. See CREDIT items: 4
2. There is a new "IRB Document Submission Received Date" if the CREDIT & IRBANA Systems are merged into one.
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08/06/2011
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*You may reply to this email if needed, it will be sent to Barbara Burke.*
CREDIT
1. The Financial Module now allows for PDF Creation for RFPs and Statements.
2. On Patient Requisitions, we have a HEADER where logos can go. We now also have a FOOTER so users can create a "Signature" block for the Investigator to sign, date, and time.
3. Staff are currently filtered per Institution they have access to. So, when adding a patient to a study, as an example, only staff load in the dropdown boxes where the staff have "Access Display" (each staff profile) to the selected Registering Institution. You may note, that if you change the Registering Institution when adding a patient to a new protocol, the "Loading...." notice appears while CREDIT retrieves the staffing for that institution. This current updater takes the step a bit further. Department Access is now also part of the filtering mix. When a protocol is selected for a patient, CREDIT now looks up the institution for the accrual, and the Department for the study selected. A double filtering (institution + department) then happens to reduce the number of selections to an absolute minimum number.
4. The Time-Task Recorder now allows for a "Default Time" when selecting specific tasks. The default is set in File Ops > Protocols > Edit Financial FTE Source Pool.
IDEA:
1. See CREDIT items: 3
2. DAR Reconcile now allows for date ranging to provide faster page loading.
3. Transferring Component to Component now has a Memo Column for each line item.
4. When entering a Destroy Agent, there is now a field for entering the "Actual Event Date".
IRBANA:
1. See CREDIT items:
2. The new IRBANA Introductory Guide is now available via the HELP icon within IRBANA. When the HELP Module opens, click on "DDOTS On-Line Documents", then locate the new Guide for downloading.
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07/02/2011
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If needed, you *CAN* Reply to this email as it will go to Barbara.Burke@ddots.com
CREDIT:
1. If the Patient Arm Notes are set to LOCKED, and the append type is set to "Prepend", the Add Notes box is at the top of the Notes Display. There is also a new "Save & Continue" button next to the Add Notes Box.
2. For Staff email distribution lists, pseudo staff can now be loaded with a listing of Email Addresses. This is handy when needing to send email notifications to "Groups" of staff without having to pick through the listing of staff to notify and adding each one to the Notification Box. As an example, a staff could be loaded with a last name of "SWOG" and first name of "Associated" and a middle name of "Staff". So the staff name is "SWOG, Associated Staff". In the Email box on that staff page, list all of the email addresses separated with a semi-colon. As an example, "Stephen.Burke@ddots.com;Carrie.Coleman@ddots.com;Patricia.Graham@ddots.com". The quote marks, of course would not be included in the email address line. So when that "staff member" is selected to be notified, it will send 3 emails out, one to each listed in the email field.
3. If the Protocol "NCT Number" is enabled on the protocol page, it is linked to the NCI NCT search page. However, if the NCT Number is already in the protocol data page, the link will go directly to that study on the NCI NCT site.
4. The Protocol Follow-up Sheets can now contain a listing of Outcome Summary for Pre-Study Screenings. To enable the system, File Ops > IRB > Edit IRB Meeting Environmental Defaults > Pre-Study. There are check boxes for selecting which screening types should be summarized on the FU Sheets.
5. The Report "Meeting Activity Reminder" now has Document Links from the study Document Library.
6. Financial Invoicing: There is now a System setting that allows for sorting Patient Invoice events by Patient ID. This keeps patients grouped together. By default, all events are Date Ordered. Main Menu > File Ops > System > System Variable Defaults > Financials > Order Invoices by Patient Protocol ID
7. Each staff member can now have a "Default IRB Documents Folder" , such that when that staff enters the IRB Documents module, only documents within that folder are displayed.
IDEA:
1. See CREDIT items: 1, 2
IRBANA:
1. See CREDIT items: 2, 5, 7
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06/18/2011
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Security Reminder: Be absolutely SURE your logon page starts out "https:". That "S" is for "Secure". Logging in with simple "http:" gets you there, but your browser will *not* be in *Secure* mode ! ! ! !
CREDIT:
1. The Patient Check-off page can now be filtered to show specific events. For example, staff can click on "Chest-X Ray" and only those will show up.
2. The Patient Search Engine OPTIONS page now allow for displaying and searching Patient Protocol Objective Status.
3. The On\Off Study Report has been updated to allow the Accrual Graph to show up when All Protocols are selected. This way, staff can pull an entire year of Accruals, and compare the Graph to a different year.
4. If the Disease Site is Enabled on the Prestudy Demographic Page, the Prestudy Listing Report can be Sort Ordered by that field.
5. Prestudy Workup Referring Staff can now be set to Required via File Ops > System > System Variable Defaults > Referring Staff Required on Workup
6. The Protocol Deviation Log now captures the list of staff where were email notified.
7. For NCI CCOPS, the Credit Summary Report now allows sorting per Investigator, Coordinator, or Data Manager.
IDEA:
1. See CREDIT items: 1, 2
IRBANA:
1. See CREDIT items: 6
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06/04/2011
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CREDIT:
1. Several Patient Adverse Event Fields can now be set to Required. They are: Site Notified Date, Treatment Given, Investigator Statement, and Suggested Changes. Each field can be independently set via Main Menu > File Operations > System > System Variable Default Values > Patient Adverse Event Required Fields. There is a checkbox for each entry.
2. There are new IRB Log entries where staff can receive email notifications. When the Action of a Revision or Amendment is changed from "Sent to IRB" to "Approved", staff can receive email. This is managed via File Ops > System > Edit Staff Notifications.
3. The Staff Task Manager now filters selectable tasks per the logon staff "Position" as assigned in each staff profile. The tasks are associated with the different "Positions" via File Ops > Protocols > Add FTE Sources of Time Expenditure. To turn this filter on, File Ops > System > System Variable Default Values > Staff > Filter Staff Tasks (in Recorder above) Per Staff Profile "Position" Selection.
4. Financial Invoices can now be created as a PDF.
5. If the "Protocol Version Date" is Enabled on the Protocol Data Page, selected staff can be emailed when that version date is changed. To set up which staff get the emails, File Ops > System > Edit Staff Notifications.
6. Staff can now be notified when a Regulatory Event Status is changed from "Sent to IRB" to Approved. To select staff for the notifications, File Ops > System > Edit Staff Notification.
7. For systems that have Patient Arm Notes Locked (entries cannot be edited) via the System Settings, the Colors selected for the Default Protocol Notes vs. the Staff Entered Notes is now active.
8. The Protocol Status "Echo" button can now be changed to follow the pattern of either the "Hospital Access List" or "Registration Allowed List" or "Neither". The default is the Hospital Access List.
9. The Time Task Recorder now allows for tagging an entry as "Payable Hourly" or "Non-Payable". If checked for Payable, the event can be included in a Request for Payment (RFP). For that feature to appear, Financials for the study must be Enabled, and the Financial Accruals Page must have an $$$ entry for "Hourly Payable Rate for Time-Task Recorder Entries". Using this feature, staff can record Doctor Time, as an example. Then, create an RFP for that Doc\Study. This allows for capture of payments made out to staff.
10. The Protocol Regulatory "Follow-up Sheets" now have Document Links imbedded.
11. When Printing an RFP it can now include a Footnote associated with the RFP Protocol. To enable the Footnote printing on a specific RFP, there is a new checkbox in the popup window when Adding or Editing a RFP.
12. The Staff License Report now allows for Editing Staff Notes directly within the report.
13. There is a new Macro available for the Patient Adverse Event Form: @AESiteNotifiedDate.
IDEA:
1. See CREDIT items: 5, 7, 8, 12, 13
IRBANA:
1. See CREDIT items: 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
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05/21/2011
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CREDIT:
1. On the Protocol Financials Invoice\Payments page, there is a new link at the bottom of the Invoice table "Create Statement". The link creates a printable statement of the account which includes all Invoices, Invoice Line Items, Item $$$, Check Number, $$$ Paid on the Line Item, and Balance Due (per line item). At the bottom of the page the columns are totaled.
2. The Patient 1 Column Calendar now displays actual Completed Dates for those events that are done, and Due Dates for events not completed.
3. The Invoice Aging report now allows for setting a Date Range. It also allows for filtering payments on those invoices to the date range, meaning that it will truncate any payments applied after the End Date.
4. The Financial Invoice Aging Report can now be Exported to Excel.
IDEA:
1. See CREDIT items:
IRBANA:
1. See CREDIT items: 1, 3, 4
2. The IRB "Submission Documents Received" Date for IRB Revisions can now be set to Blank by default. File Ops > System > System Variable Default Values > Default Dates to "Today" when Adding to IRB Log Pages. This is the first date to be impacted by this new setting. More may be bundled under this setting as staff request this feature. Disabling this option will result in a Blank Date with the "Today" link available for populating. If this feature is Enabled (default) Today's date will automatically be loaded.
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05/07/2011
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CREDIT:
1. There is a new Checkbox in the System Setup to allow IRB Document Submission Dates to be Required.
2. The IRB Follow-up Sheets are now Date Ranged.
3. The protocol Financials page has the NOTES moved to the top of the page.
4. We are just starting to put the Protocol Summary into the download files from the DDOTS Protocol Library. Going forward, the Summary will populate when the protocol is Imported into CREDIT. Historical studies will not have the Summary. Further, for the Summary to appear on the Protocol Data Page, it must be Enabled in the File Ops > System setup.
IDEA:
1. See CREDIT items: 4
IRBANA:
1. See CREDIT items: 1, 2, 3, 4
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04/23/2011
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There are 3 new "CREDIT Introductory Guides" in the Help > DDOTS, Inc. On-Line Documents > Library.
They are the "Protocols", "File Operations" and "Financials" Guides. Please download, print, and update your CREDIT Notebook with these new releases. The "Pre-Study" and "Patient" Manuals have recently been updated as well.
Also, visit us at the Seattle ACRP Global Conference Booth #623, April 30 thru May 2.
DDOTS now has available the "CTSU NCI CIRB" Form. If you wish to have this added to your Documents Module such that it can be merged in the Regulatory system, please send an email to DDOTS and request this form be loaded into your specific site. This is the "Acknowledgment Form (for sites utilizing the NCI CIRB)".
CREDIT:
1. If the Patient Check-off Calendar has Patient Requisition events scheduled, those Due Dates have a link to popup the Requisition controlling the Event. The Requisition Number and Date also appear on the Master Schedule Report.
2. The Protocol Monitor Log now allows for "Also Record\Upload Documents For:" selected Protocols.
3. When adding a new zipcode to prestudy and\or patient file cabinet, the popup has been eliminated and replaced with on-page prompting.
4. There is a new table available in the NCI\CCOP Reports: Continuation (Type 5) CCOP Performance Sites Summary.
5. Pre-Study Screening has been modified to allow "Drill-down" from the Disease Site thru available Protocols. The process allows for selection of a Disease Category, then a specific Sponsor or Disease Site. With those selections, Protocols are loaded that meet those selections. Finally, as a protocol is selected, the Protocol Eligibility is shown for the specific protocol.
6. Patient Requisitions can now be Exported to Excel or Word.
7. The Link Patients & Protocols Report now allows Sorting by Patient Date of Death. This will facilitate staff locating patients whose records can be Archived. Additionally, for some filtering on that report, there is a new Date Range selection. That range is active for when patients: 1) Went off Treatment, 2) Went Off Study, and 3) Were Deceased.
8. For institutions with multiple Components Institutions, the "Echo Status" button now only resets Component Institution Status IF "Allow Patient Registration" checkbox has been checked for that Component Site.
IDEA:
1. See CREDIT items: 3, 7, 8
IRBANA:
1. See CREDIT items: 2
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04/02/2011
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CREDIT:
1. The Master Schedule Report now allows for Ordering the output by Patient ID.
2. Prestudy Workups now allow for selection of "Referring Staff". Further, the Prestudy Listing Report also has that as a Column to Include and ability to Sort via that column. And, it is not just Docs who are selectable. In each Staff Profile, there is a checkbox under Capabilities: Referring Staff. It pulls staff who have that box checked.
3. Added "Target" and "Actual" Accruals as Column to Include in the Protocol Status Report.
4. The Patient Requisition Form now has the ability to filter Patient Calendar Events for a date range. Setting the date range, the Form now pulls events directly from the Patient Calendar where events are not yet completed, and fall into the date range. Including Calendar Dated events in the Requisition connects the 2 events together, which means only one Req per event is allowed. This eliminates the possibility of double requisitions for the same calendar events.
5. When collecting Patient Milestones for Invoicing, if there are zero ($0.00) valued Milestones in Patient Calendars that are of "Type Financial", a new link can force those events into the invoicing popup. The new link is at the top of the Milestone Collections module and is an On\Off flag:
Reload Including $0.00 Value Milestones
vs
Reload Excluding $0.00 Value Milestones
IDEA:
1. See CREDIT items: 1
2. When a DAR has an action of "Destroyed", and the entry comes from the Destruction module with a standard "Reason for Destroy", echo that reason in the Action cell of the Destroy entry.
3. If a Dispense is done from an inventory that is Patient Specific for Inventory, there will be one additional DAR entry noting the quantity transferred from that inventory to the Dispensing Patient Specific Inventory. After that entry, the Dispense will appear as it has in the past. This initiative is to facilitate the ability to produce true Patient DARFs that represent drug that originated in Patient Specific for Inventory, and were eventually assigned to a specific patient.
IRBANA:
1. See CREDIT items:
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03/19/2011
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CREDIT:
1. There is a new Financial Report: "Billing Compliance Report". It pulls data from the protocol financials: Patient Billing Compliance.
2. The Consent Form Log now allows for "View" mode vs. "Record" mode. The report can also be Exported to Excel.
3. There is a new "Comment" field next to the Ethnic Race and Ethnic Category on the Patient Photo (Demographic) page. It allows for explanation about the Ethnic selection chosen.
IDEA:
1. See CREDIT items: 2, 3
2. There is a new "Agent DARF" available. Once the Agent DARF has been loaded, there is a new link at the bottom of the page to "Generate PDF". That link creates the NCI DARF. Once the creation is completed, a new link appears to "Download PDF". That link opens up the NCI DARF for the Agent involved. It is intended that this version of the DARF will meet the needs of auditors who are expecting the NCI DARF. Future plans call for the development of additional DARFs in the NCI Format. Patient DARFs are next in line and should be released within a few weeks.
3. For drugs that are Patient Specific or Patient Specific for Inventory, in the View Inventory module, the drugs can now be Reassigned to a specific patient, or back to "For Inventory".
IRBANA:
1. See CREDIT items:
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03/05/2011
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CREDIT:
1. The Protocol Monitor Visit Log now has hourly increments reduced to 1/4 hour increments.
2. The On\Off Study Report can now be sorted by Coordinator or Data Manager.
3. Each Protocol Financial Module can now be set up to capture tasks from the Time-Task Recorder. Inside the protocol financials, on the Financials: Accruals page, there is a new field: "Hourly Billing Rate for Time-Task Recorder Entries". When a dollar amount is loaded in the field, it triggers the Milestone Collection module to capture Time-Task events associated with the study. These events become part of the Invoice, as well as Payment Allocation. This new financial module is also reflected in all of the Financial Reports. Key to using this module is the entry of $$$ in the new field, *and* tagging all Time-Task Events to the specific Protocol. Selecting a Prestudy Subject or Patient is optional. But if selected, those subjects will be included in the Printed Invoice.
IDEA:
1. See CREDIT items: 1
2. The Patient DARF now includes new buttons to popup the Patient Calendar as well as the Patient Manual Events environment.
IRBANA:
1. See CREDIT items: 1
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02/19/2011
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CREDIT:
1. When adding a staff, there is now the option of Bulk adding that staff to Protocol Research Teams.
IDEA:
1. See CREDIT items: 1
IRBANA:
1. See CREDIT items: 1
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01/29/2011
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CREDIT:
1. The Prestudy Listing Report now allows filtering by Screening ID Key Word.
2. The Link Patients & Protocols report now allows for sorting by Department.
3. There is now a "Date of Death" field in Prestudy. That date is linked to the Patient File Cabinet Date of Death. If one is changed, it changes the other.
4. The Prestudy Listing Report now allows filtering per All Patients, Alive Patients, Deceased Patients.
5. The Staff Pager has been added to the Staff Information Report.
IDEA:
1. See CREDIT items: 5
IRBANA:
1. See CREDIT items: 5
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01/15/2011
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CREDIT:
1. There is a new Revision Log Report available in the Reports Page. It is listed under the Protocol Column.
2. There is a new Review Log Report available in the Reports Page. It is listed under the Protocol Column.
3. On the Protocol Data Page, if there IS Regulatory for THIS IRB, and staff is Changing IRB of Record to another IRB, the user is now prompted to Move Regulatory Submissions over to the New IRB of Record.
4. When a new patient is accrued to a study, Email Notifications can be sent directly from the page where the patients is attached to the study.
5. There is a new Email Notification system in the Protocol and Patient Deviation Logs.
6. The On\Off Study Report now allows for Registering Physician Patient Count totals. For this feature to function, the Sort Order must be set to Investigator, and the checkbox to the right must be checked: "Subtotal Patient Count". Further, the Investigator Column needs to be checked as well.
7. When Collecting Financial Milestones, the Reviews and Revisions now display the IRB associated with the entry.
8. The Protocol Current Status Report now allows for selecting column: Protocol Website Links. The links are loaded in each protocol via the Mini-Menu.
9. Each Logon Staff member can have a "Default Sponsor" set in their Staff Profile. That way, when adding patients to protocols, that specific sponsor is automatically selected, and protocols for that sponsor are loaded.
10. There is a new button in the IRB Document Library: Copy Folders. When the button is clicked, the page refreshes with all folder names from all other protocols. This eliminates the need to re-select specific folders for a given study.
11. Sometimes when patients are accrued to a study, they need to be "Randomly Assigned" an Arm by the system. This feature is now available, and requires some setup to make it all happen. First, into File Ops > System > Protocol Data > Show Protocol Arm Randomization Pattern List > Enable. This feature allows for a text box to appear on the protocol data page allowing for the Random Arm Assignments to be loaded. Using a random arm generator, create the list of arms. Then load those arms into the new field in CREDIT, separating each one with a comma (,). So, the data might look something like this: 1,2,2,2,1,3,3,1,2 or B,A,A,C,A,B, etc....
Then, when a patient is accrued to the study, CREDIT will take the first entry, assign it to the patient, then remove it from the list. So the list shrinks as patients are assigned. The user will not know which arm is assigned until the full patient & protocol page is saved.
12. There is a System Default Sponsor for assigning patients to protocol. That sponsor is loaded and the protocol for that sponsor loaded when the Add New Protocol to Patient module is initiated. Now, however, there is a staff-specific Default sponsor that can override the System Default. Each staff has a new dropdown to select the default sponsor. So, if Mary selects CALGB, and Bob selects SWOG, and Carrie selects BMS, those default sponsors will be loaded at the time of patient assignment to protocol.
IDEA:
1. See CREDIT items: 4, 9
2. There is a new Auto-Receival system in place that facilitates Patient Specific Drug. The updated system prompts for Lot # and number of Unique Container IDs for each Lot. When the final page loads, lots are grouped together to allow Inventory to store selected quantities together instead of separate line entries. However, each Unique Container ID will create a separate Inventory and DAR line entry.
3. If there is a bottle with zero in side of it, the Destroy now allows for destruction of the empty vessel.
IRBANA:
1. See CREDIT items: 1, 2, 3, 5, 8, 10
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12/18/2010
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CREDIT:
1. If Patient Arm Notes are Locked, the Original Arm Notes from the Protocol are displayed in Blue, while the Staff entries are displayed in Black.
2. Each Patient Reasons for Withdrawal can now be set to In-Active in File Ops. When set to In-Active, the Withdrawal Reason no longer appears in the patient dropdown box as selectable. However, it the patient already had that selection made, the reason does show up, but is colored Red. In this event, if the Red Selection is changed to any other "Reason" and saved, that Red Selection is no longer available when the page reloads.
3. The Patient Search Engine now allows for searching for Patients per Investigator, Coordinator, or Data Manager.
IDEA:
1. See CREDIT items: 1, 3
2. There is a new option to select in the Pharmacy Mini-Menu for each study: "Patient Returns". This new module allows for staff to select the patient, then the Dispense the return is associated with. From there, selecting the Quantity Returned, and the option of having a Memo is available. Once saved, the staff returns to the unique "Patient Returns DARF". The Return entries are seen in the Master Protocol Summary DARF (which should never be presented for Audit), however, the Returns are not displayed in either the Agent DARF nor the Patient DARF. This process eliminates the "Pre-Populate" and "Destroy" entries previously required for Patient Returns. Further, the new Returns do *not* add any stock back into Inventory.
Further, the system allows for Drug Returns for patients that were previously not Dispensed via IDEA. The Patient Calendars are gleaned for Provided Drug Events that were completed. Those events can now be involved in Patient Returns via IDEA.
IRBANA:
1. See CREDIT items:
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12/04/2010
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CREDIT:
1. The previous updater enabled Email Notification of Document Upload per IRB Review History Log and IRB Revision Log. That email capability can now be controlled via File Operations > System > System Variable Defaults > IRB Activities. The very last entries Enable vs. Disable the feature. Be default, they are set to Enable.
2. The Time Task Recorder now allows for the entry of the task Starting and Ending time. The Recorder calculates the hours and minutes from the selected times. The Time Task Report then shows the Start and End Time for each task.
3. The IRB Document Library System has been rewritten to condense all study documents. Now when a document is uploaded, it can be "Tagged" as a Patient Document (or not), which means it is available on the Patient Side. This totally eliminates the need to upload documents twice... once in the IRB Document Library, and once in the Patient\Protocol Forms. One upload, and tagged for display or not on the patient side. So, when a new Consent Form needs release to the patient side, simply uncheck the box for the old Consent Form and Save. Then upload the new form and check the box to Release to Patient side. All existing Patient Side documents have been merged into the IRB Document Library. We have yet to remove the Mini-Menu Link for Patient\Protocol Forms, and the link continues to work. However, the link points directly to the IRB Document Library now, filtered for Patient Documents. There is a dropdown box at the top which allows for loading the entire IRB Library vs. just Patient Documents.
4. The On\Off Study Report now allows for selection of Multiple Locations (if Locations is enabled in the System).
5. The On\Off Study Report now allows for Separate Data Columns for common combined Data Columns. As an example, under the default setting "Join Data Columns When Possible", the data column for "Off Tx" with "Reason" will fall into one single column, with a (Return) between the data:
| 11/23/2010 |
| Completed |
However, choosing the "Separate Data Columns" Data Format Option, the data will be displayed in 2 columns rather than being stacked.
| 11/23/2010 | Completed |
6. The On\Off Study Report now allows for display of NCI CCOP Credits if the institution is a CCOP or Component of one.
7. In File Ops > Edit Staff, each staff can have Staff Licenses "Archived" (via a check box per recent update). Now, by default, those licenses are "Hidden" when the page loads. This cleans up the page showing only active licenses. A simple link is available to "Show\Hide Archived Licenses"
8. The new IRB Documents Library (previous updater), that now houses ALL Documents, has a new set of "Library Filters" that allows the user to select which Documents to Display. The new options are "Exclude Protocol\Patient Documents", and (if IRBANA), "Exclude New Documents for Review". When these selections are made, the page reloads per the selected Library Filter. The DEFAULT Library Filter can now be set in File Ops > System > System Variable Defaults > IRB Activities > (last entry).
9. There is a new "Work Phone" field on the Patient Demographic Page.
IDEA:
1. See CREDIT items: 9
2. During a Dispense, if there is a need to Add a Manual Event into the patient calendar (button upper right of Dispense Page), when the popup window loads, only the drugs associated with the study will be selectable. Further, if there is only 1 drug, it will be selected by default.
3. The Protocol DARF now has a button link at the bottom of the page to "Show Patients".
4. The Protocol DARF now has a link to "Show/Hide Pharmacy Notes".
5. When an Agent is Destroyed, a memo is now required. Alternately, there is a dropdown box with Default Reasons to select from. If a Reason is selected, anything typed into the Memo Box will be appended to the selected reason. The Destroy Reasons can be edited in File Ops > Pharmacy > Add \ Edit \ Delete Agent Destroy Reason.
6. Our lookahead system has received a complete overhaul. Previously, the lookahead would produce erratic results for installations with multiple pharmacies as it didn't quite know which pharmacy would be doing the dispense. Without knowing where the dispense would happen, it could not completely be relied upon to accurately estimate future supplies.
However, with the new upgrade, dispensing pharmacies are now required to be set for accrued patients on an agent/unit/dosage basis. Once it has been set it never needs to be set again unless you need to change it. When adding a patient, you can choose a single pharmacy and it will map out to all of the agents. If you need to further refine it for
each agent, you can do so in the Event Focus area of the Patient Protocol page (while in "Edit" mode). On the pharmacy side, these mappings carry through for the lookahead.
Additionally, they carry through for the dispense itself and, in fact, will not allow you to dispense for a patient event that is tied to another pharmacy. However, at the top of the page, we alert you to any events that are set for other pharmacies and it's only a single button click away to "claim" that patient event for dispense in the current pharmacy. So, for example, let's say a patient always receives their dispenses at Pharmacy A. However, due to circumstances, they will actually be getting dispensed from Pharmacy B for their upcoming dispense. When you log into Pharmacy B and attempt to dispense (as you normally would), you will see the patient event correctly tied to Pharmacy A.
You can simply click the "Reassign to Current Pharmacy" button for that patient event causing the page to reload with the patient now assigned to the current pharmacy and ready for dispense. They will remain with Pharmacy B for that specific agent/unit/dosage for future dispenses (although you can quickly claim them back with Pharmacy A with the same technique). All of these changes help to strengthen the auditing and predictive features of the IDEA module without adding any time-consuming processes, instead making pharmacy changes literally a button click away.
IRBANA:
1. See CREDIT items: 1, 8
2. Please note #3 above. The "New Documents for Review" have also been moved directly into the IRB Document Library. The report that allowed for the documents to be MOVEd, now allows for the removal of the New Document Flag which releases the document into the general IRB Documents Library. The folder can also be assigned at the same time.
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11/06/2010
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CREDIT:
1. There is a new feature that allows for turning off "Patient\Protocol Document" "Forms" on the patient and\or prestudy modules based on the Status of the Protocol. So, if a study status changes to Temp. Closed, as an example, the FORMS button can be hidden to prevent users from grabbing forms that are "locked down". Once the status changes back to OPEN (or other selectable settings), the button will reappear. This is managed via File Ops > System > System Variable Default Values > Patient\Study (at the bottom of the section).
2. Protocol ORC Event Entries can now be "Bulk Loaded" per the Default setting of the event in File Ops > Protocols > Edit ORC Event. Each Event can now have a "Default Load" option that will queue the event up such that any protocol ORC page can load the events with the click of the button "Load Default Events". The button creates a popup window that allows for checking and un-checking the "Load" checkbox for each entry.
3. If Protocol Financials are enabled for a study, the Financial Accruals page, Continuing Review Value and Revision Value are now key in determining if the Review and Revision Logs have the default set to Billable vs. Non-Billable. If there are $ Values on the Accrual page, the defaults in the logs will be Billable. Otherwise, the default setting in the IRB Review (and Revision) Log will be Non-Billable.
4. IRB Document Folders can now be Added\Edited via File Ops > Protocols > Edit IRB Document Folder. This allows for changing of names of folders. This action is universal for all studies! So if the change is from "Letters of Approval" to "Approved Letters", every protocol document that had the old entry, gets the new entry, no exceptions.
5. The IRB Patient\Protocol Forms Library now has "Folder" capability similar to the IRB Documents Library.
6. The new Prestudy Bulk Screener (Main Menu > Prestudy > Mini-Menu: Add Bulk Screenings), now allows for the entry of the Screening Location.
7. The Protocol Data Page is loaded with many dates. These dates are Enabled or Disabled via File Ops > System > System Variable Defaults > Protocol Data. Now, there is a new option to Enable Notes for all of the date fields. Be default it is disabled. If Enabled, a small note box will appear to the right of each Protocol Date, allowing for text entry to document the date value.
8. When editing a protocol, there has always been the SHOW PATIENTS button in the toolbox. When the patient listing comes up, there are links to various pages for each patient. Those links now allow for SAVING data on the pages that load in the window. Prior to this update, the pages loaded, however, there were no SAVE buttons on the pages. After Saving changes to any of the pages, the SHOW PATIENTS window reloads with the updated information.
9. The IRB Patient\Protocol Forms page now displays "Patient Calendar Notes" from the Protocol Data page if that text box has information loaded.
10. There are several new Macros for merging the New Patient Form:
AuxDocTypexx
AuxDocNamexx
AuxDocAddressxx
AuxDocCityxx
AuxDocStatexx
AuxDocZipxx
AuxDocPhonexx
AuxDocFaxxx
Where "xx" is a numeric: "01", "02",....."10", "11", .... etc.
The numbering can go to 100 Aux Docs per patient.
Example:
@AuxDocType01
@AuxDocName01
@AuxDocAddress01 @AuxDocCity01 @AuxDocState01 @AuxDocZip01
Ph: @AuxDocPhone01
Fx: @AuxDocFax01
11. The Staff License Report now has links to open the Licenses (if the License has been uploaded).
12. The Protocol Research Team now has an "Email" link next to the each member listing if the staff email address is in the staff profile. The link pops open the email environment to send an email to the selected staff.
13. There is a new User Defined Fields (UDF) in File Ops > System. The new module allows users to create a wide variety of fields from Dropdown Boxes, Check Boxes, Radio Buttons, Text Box, etc... Each Field has its own Title, Type of Field (as noted above), and potential answers to select from. For instance, a UDF could be made for "Color of Eyes", and it could be a Dropdown box. Then the dropdown box could be filled with selections: Blue, Brown, Green, Other... The UDF offers to be available on several pages in the system: Patient Page, Patient Protocol Page, Prestudy Page, Prestudy Workup Page. For those UDFs that are assigned the Patient or Prestudy Pages, the same field can "Peek Through" onto the Patient Protocol Page as well.
14. The Current Status Report can now be Sorted by "IRB of Record".
15. When in the Protocol Arm Design Page, there is a new Mini-Menu option: "Import Events from Other Arms". This new module allows for loading the existing Arm of a study with the elements from other existing arms. When the page loads, it allows for checking the events to import. Note: This importer does *not* schedule the events, it simply lists them for scheduling in the existing arm. The reason we cannot schedule (check the time frame boxes), is that events from various arms are not guaranteed to have the identical segment duration nor segment type.
16. The IRB Logs: Review History and Revision Log now have the ability to Email staff for Document Upload Notification. Notifications will only be sent if one or more documents is uploaded when adding the new log entry.
IDEA:
1. See CREDIT items: 7, 12, 13
IRBANA:
1. See CREDIT items: 4, 7, 11, 12, 16
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10/09/2010
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CREDIT:
1. The Protocol PI now displays in the Protocol Toolbox below the Mini-Menu.
2. The Protocol Research team can now have specific "Participation Tasks" or "Functions" or "Duties" associated per protocol. There is a "File Op > Protocols >Protocol Staff Participation Options" link to manage the selections available for the Research Team.
3. The Prestudy Bulk Screener now has a memory such that values from the previously entered screening default in the dropdown selections for the next addition.
4. The Patient Protocol Arm Notes have had the ability to be "Locked" for a couple of years now. This newest update allows for setting the order of the data when saving. The default order is "Date, Staff, Note". In FileOps > System > System Variable Defaults > Patients\Study > Lock Patient Arm Notes when Saved, there is now the option of setting the data order. Further, there is an option to have the newly added notes Appended to the End of existing notes, or Appended to the Top of the existing notes. The default it Append to End.
5. The Patient Data Management Log now allows for updating the Request and Due Dates for events that are Self-Repeating. A simple check box allows for designating which entries to update. The new Request Date is loaded and there is an "Update" button that submits the request. Only Self-Repeating entries can be updated as the Self-Repeating values are used to compute the new Due Date.
6. The Patient Data Management Log now allows for creating future entries based on the Self-Replicating entry. Originally, the new event were created when the existing entry was completed. Now, when a new entry is loaded, there is a check box to "Create All Entries Now!". Checking the box does not simply que up future log entries, it creates the entries immediately. For this feature to work, there MUST be a Self-Repeating Limit. The value loaded into the Limit box will be the number of *additional* log entries to make into the future.
7. Financial Direct Costs has a Notes feature. Traditionally those notes for each Direct Cost appeared on the Invoice along with the Direct Cost Description. Now, however, there is a checkbox next to the Notes in the Direct Cost page. Checking the box denotes that the Notes should be included on the Invoice. Unchecking the box eliminates the notes from appearing on the Invoice. Each Direct Cost entry can have the notes turned on\off for Invoice printing. The default is ON for all existing events. Those events can be edited to uncheck the box for invoice printing.
8. When Financial Milestones are collected for Patient Calendar Events, the event notes can now be included in the Invoice Printout. There is a new checkbox next to each note for each calendar event when collecting milestones. Placing a check in the box for selected patient events insures that the note listed will be printed on the invoice. If the box is left unchecked (default), or the notes are blank, the notes will not be printed on the line item for the invoice.
9. Financial Requests for Payment (RFP), also now allows for line-item note inclusion in the RFP Printout.
IDEA:
1. See CREDIT items: 1
2. The Protocol DAR now has a new button at the bottom of the page "Pharmacy Notes". The button pops up an Editor to allow for adding text to the note. Font, color, and size are all capable in the editor. Once saved, a window will show the note and prompt to "Close Window". The DAR will need to be refreshed to show the note pad.
IRBANA:
1. See CREDIT items: 1
2. When logging Voting for any event, if the IRB Member is also part of the Research Team for the protocol, the user is alerted to Recuse that member.
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09/18/2010
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SUMMER 2011 SEMINAR in Ann Arbor?
If you are interested in attending a 1 or 2 day training session in Ann Arbor next Summer, let Barbara know.
If there is enough interest, we can schedule the days and let everyone know!
CREDIT:
1. The Patient Requisition Forms can now have 3 columns enabled or disabled via File Operations > System > System Variable Defaults > Patient\Study.
Show "Requested From"
Show "Bill To"
Show "Done" check box.
2. Patient and Protocol Audit Topics and Sub-Topics can be set to "Not-Active" via File Operations. This way, new topics can be added, and others decommissioned.
3. The Patient Data Management Log now allows self-repeating Forms to have a Repeating Limit. So, if a form is to be re-created (upon completion) 6 times, loading the limit of 5 (indicating we will need 5 additional forms generated along the way), when each form is completed, there is a countdown to zero. When zero is hit, the form will stop re-generating. Optionally (default), leaving the Limiter blank will cause the form to re-generate until the staff shuts it off by hand.
4. There is now a quick way to add subjects into the Prestudy Screening module. Once in Prestudy, the Mini-Menu now has the option: "Add Bulk Screenings". This new page allows for simple entry of Protocol, Disease Site, Patient Name, Time Invested, Investigator, Outcome, Contact Type, and Notes. When an entry is made, that entry is returned to the page with a link to edit the patient workup. The page is then immediately ready for another screening entry. This new module adds the patient into CREDIT, and creates a Workup all at the same time. One page, one button to click on!
5. On the Patient Check-off Calendar, there is a new "All" link for Completing All Events for any given date.
6. When allocating funds to invoiced items, the "Line Item Account" is now shown for each invoice entry (if a Line Item Account was assigned at time of Invoice).
7. Primary and Secondary Language selections are now available on the Prestudy Patient Page. If this feature is Enabled in the Patient Photo (Data) Page, it will appear on the Prestudy Patient Page. This feature can be Enabled via File Ops > System > System Variable Default Values > Patients & Prestudy Pages > Show Patient Languages
8. When adding a new Protocol Adverse Event into the Log, the "ID" field is now set up such that each keystroke causes the system to inspect existing AE entries for duplicate IDs. At each keystroke, either the message "This is a unique adverse event identifier" appears below the ID Entry Line, or the message "This is NOT a unique adverse event identifier" message appears. The ID inspection looks for exact matches, spaces, dashes, pound signs... etc.
IDEA:
1. See CREDIT items: 5, 7
2. The Protocol DARs now have a link to Transporting Pharmacies. If inventory was transported TO or FROM a Pharmacy, the link on the DAR will load the protocol DAR for the selected pharmacy.
IRBANA:
1. See CREDIT items: 2, 8
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08/28/2010
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CREDIT:
1. In the Patient Checkoff Calendar, if the Auto-Comment feature is used, there is now a checkbox that allows for "Ignore" events that get the Auto-Comment.
2. There is a new System Variable: Flag Patient Calendars when Protocol Status is set to: [--- Select Status ---]. If a status is selected, that status will show up on the Patient Protocol page when the protocol status is set to the Flag Status. This Flag is provided to alert staff that a study is "Permanently Closed" (as an example), and that no follow up data need be submitted.
3. If the Protocol NCT Number is Enabled in File Ops > System > System Variable Default Values, the title on the protocol page will be linked to:
http://www.clinicaltrials.gov/ct2/search
IDEA:
1. See CREDIT items: 1, 2
IRBANA:
1. See CREDIT items:
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08/14/2010
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CREDIT:
1. Many Patient Data Management forms are the same, but spelled differently. You can now select the form you want to preserve, and select the other forms that you want to BECOME the preserved form. Main Menu > File Operations > Patients > Edit Data Management Form for Patients
Select the entry you want to KEEP, then select the entries you want to condense into the Keeper. This allows you to clean up you Forms File very easily ! ! !
2. There is a new feature in the Patient Protocol Page that allows for Moving a patient from one Arm to another. The existing "New Arm" button will have the option to ADD the patient to another Arm of the study, or MOVE the patient from the existing Arm to the newly selected Arm. This eliminates the need to Delete the old Arm after the patient is added to the new Arm. Further, all existing Adverse Events, Data Management Forms, Deviations, etc... are preserved in the Move and are automatically attached to the new Arm.
3. The Patient Data Management Report now has a Memory to remember your settings from the last time the report was run. Further, the report can now be sort Ordered by Investigator. If that option is chosen, each Investigator will have the number of Forms Totaled.
4. The Report "Status Change by Date" now includes additional "Columns to Include". User Memory has also been added to the report such that selections will be remembered session to session per staff member.
5. IRB Document Uploading and Patient\Protocol Document Uploading has been modified to allow selected staff to be emailed a notice. Prior to this update, only staff that were tagged to be notified, and the Research Team for the study could be emailed. Those staff are now set to the Default Staff to Email, however, they can be Removed and others Added as needed. By default the "Notify These Staff" checkbox located above the staff list is Un-Checked. In that mode, no emails will be sent. Staff need to check the box to confirm that they DO want the emails to go out to the selected staff. Additionally, when the Log of Documents uploads, the "Staff Notified" column will contain a linked "Yes" that will popup the names of those emailed.
6. There is a new Protocol Module: Surveys. This allows for creation of surveys for patients associated with the protocol (or multiple protocols). Once the survey is created, the Survey link appears in the Patient Mini-Menu. On the Patient Side, the surveys are filled in (from printouts given the patient). Back on the Protocol Side, there is a STATS link to provide reporting about the survey results.
7. There is a new setting in File Ops > System > System Variable Default Values > Staff > Email Staff Directly to Warn of Expiring Licenses. By default this is Disabled. If you wish staff to be notified via email, it should be enabled. Notice that emails can only be sent to staff who have their email address in their staff profile. Email notices will be send xx number of days before expiring, then again on the date of expiration, if this feature is Enabled. Of course, the Notification System for staff remains active as other staff can receive email notices of staff licenses that are expiring.
8. The Patient Data Management Log now allows Deletion via checkbox directly on the Log Page.
9. When a Form is logged in the patient Data Management Log, the Due Date may be left blank *if* there is a value in the Repeating box. In this case, the Due Date will be calculated from the Request Date adding the value of the Self-Repeating box. For this feature to work, the Due Date *must* be blank.
10. On the Patient Protocol Page (Event Focus), when the Hospital or Registering Institution is changed, the Doctor Dropdown boxes are reloaded with only Doctors that have the selected hospital associated with the institution. The association is provided via each staff profile in the Hospital Access section. A new column "Display" keys the specific staff for inclusion in dropdown boxes for selected hospitals. This is the first step of Staff-Specific association with Hospitals and Departments. So, at this time it is possible to associate a Doctor only with hospitals that are appropriate. This will eliminate sifting through a long list of Doctors who are not associated with the hospital of record for the patient.
IDEA:
1. See CREDIT items:
IRBANA:
1. See CREDIT items: 4, 5
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07/24/2010
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CREDIT:
1. The Meeting Activity Recorder now allows for the "Notation" column to be included.
2. Several updates earlier, the Protocol Data page began showing a partial display of the Annual Review Memo field. This data is only displayed when the Peek-Thru is enabled in File Ops > System. Now the Annual Review Data can still be displayed without the Memo data showing. To turn off the Memo field from displaying, there is a checkbox that needs to be unchecked. File Ops > System > System Variable Default Values > Protocol Data > Show Initial Protocol IRB Approve Date on Data Page. The checkbox is to the right of the option to Enable: "& Show Memo".
3. The Protocol Follow-up Sheets now have the Review History in a normal data table for display.
4. There is a new Patient Email system in Reports: Bulk Email Report. This new module allows for sending emails to selected patients based on filtering. Documents can event be attached to the email. Once the filtering is set (say for all patients still on study for S0000), an email Subject is needed and the typed message can be entered. Then, optionally, files can be attached. When the Create Report button is clicked, the next page shows all the patients who will get the email. Optionally on that page, patients can be un-checked to remove them from the listing.
5. There is a new Staff File: "Personal Notes". The intent here is that information typed into this new field will only be displayed in the Staff Profile Page for privacy. This field will not be included in any Reports, therefore staff can have things like personal cell phone numbers, personal contact information, etc.... in the new text box.
6. The Protocol Treatment Report now allows for selection per selected drugs, or All Agents.
7. In File Ops > Edit Hospital\Affiliates, there is now a Notepad for each institution.
8. Staff License Expire Notices have historically been simple System Mail and not true "Email". The system has been upgraded and will perform as follows: If a staff has an expiring License, that staff will receive a warning Email xx Days before the date of expire (xx managed by System Settings). Then, on the day of Expire, the staff will receive another email. All of this precludes that the staff has a valid email address in their staff profile. Additionally, staff listed on the Notification List for Expiring Licenses will receive the traditional System Mail notifying them of expiring licenses. Please note that the new configuration may result in a one-time numerous System Mail being sent to the Staff of Notification as it clears out existing entries.
9. When a Protocol External Adverse Event is added, and multiple protocols are selected, any Attached Uploaded Document(s) will also be uploaded for the additional protocols selected. Each protocol gets a unique file name for the upload. Deleting an Attachment from one Protocol does NOT delete the attachment from other protocols that where multiple loaded in the original ADD.
10. The Staff License Report now allows for filtering per staff. By default all staff are selected. Radio buttons for "Active Only", "Resigned Only", "Active and Resigned" will reload the staff selection box based on whether or not the staff has a Resign Date in their profile.
IDEA:
1. See CREDIT items: 5, 6, 7, 8
IRBANA:
1. See CREDIT items: 1, 2, 3, 5, 7, 8, 9, 10
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07/10/2010
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CREDIT:
1. The On\Off Study Report now allows for selection of Disease Site as a filter.
2. When creating a Data Management Log entry, the system now has Email Notification capability. By default, the Research Nurse and Data Manager are pulled into the Notification List. These can be added to or removed by the user. Only staff with Email Addresses loaded into their staff profile are available for selection.
3. There are 7 new Macros that can be used for Patient Merging:
@InvestigatorStreet
@InvestigatorStreet2
@InvestigatorCity
@InvestigatorState
@InvestigatorZip
@InvestigatorPhone
@InvestigatorFax
4. The IRB Adverse Event page has had a make-over. There have been many requests over the last few months to somehow shrink the page. And that is exactly what has happened. When the page first loads, none of the existing AEs are displayed. There is a new link at the top of the page to SHOW Adverse Events. Clicking that link loads the page with all the existing events that have been added over the history of the study. If the page is in SHOW mode, a new link is available to HIDE Adverse Events. When the AEs are in Show mode, the space required by each AE has also been reduced. Font size is smaller and the links to EDIT, Form: Print\Word, Document: Print\Word are all clustered in the Memo Cell. This page design is from our new DDOTS Member: Jamie Samland!
Further, You can change the default if you want to HIDE via File Operations > System > System Default Variables > IRB Activities > Hide External Adverse Events when Page Loads
The default is DISABLED, so the page will not Hide the events when it loads up.
5. When editing an existing Staff Member, the name of the staff floats on a bar of the screen to remind staff which member is being edited.
6. If Patient Follow-up Locations is Enabled, there is a new feature to allow each Location to be INACTIVE, which stops the Location from being available for New Accruals.
7. The Staff Information Report now allows filtering by Staff Position.
8. When Patient\Protocol Documents are uploaded, the list of Organizations that are allowed Access to the document are defaulted to only Organizations that are set to ACTIVE in the Edit Hospital\Affiliate File Operations page. Further, there is now an "all" and "none" that is associated with the check boxes for Access.
9. When a patient needs re-consenting, a notice shows up on all patient\protocol pages for the patient. This feature has been enabled for several years. Now, the ID of the event is also displayed and is linked to a popup alert box that details the elements of the IRB Event that caused the re-consent. Additionally, on the Patient Consent Log Page, the entries are also linked to pull information from the IRB Event, if appropriate.
IDEA:
1. See CREDIT items: 1, 3, 5, 6, 7
IRBANA:
1. See CREDIT items: 4, 5, 7
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06/21/2010
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CREDIT:
1. The Link Patients & Provided Agents report now allows for multiple Institution Selection as well as new columns to include: On Study, Off Treatment, Off Study.
2. The Protocol Current Status Report now includes the Reviewing Agency, and Review Action as a part of the existing Columns: Last Review Date, Last Review Activity Date, and First Review Date.
3. IRB Document Notes can now be hidden to save on page display space. A default (Hide vs. Show) is available to be set in File Ops > System > System Variable Default Values > IRB Activities > Hide IRB Document Notes on Page Load (By default the setting is set to Disable, which means display the notes when the page loads). When the page displays notes, there is a "Hide" link to reload the page hiding the notes from display. When hidden, there is a "Show" link to toggle the Notes to display again.
4. For CCOPs that have enabled Patient Calendar "Schedule Starts Date", there has been the problem that the Crediting Date falls on *that* date and not the On Study Date. Often staff simply check the Credit event off without moving the Complete Date back to the On Study Date. If this is an issue at your site, there is now a new feature in File Ops > System > System Variable Default Values > Patient\Study > Move Initial NCI Credit Due Date to On Study Date. If this feature is Enabled (it comes as Disabled), then when a calendar is created for the Patient, CREDIT will look for any Crediting Event on the Schedule Starts Date, and shift the Due Date of that back to the On Study Date.
As an example, if the Date of Randomization for a patient is May 25th, but the Schedule Starts Date is June 5th, normally, the Credit Due Date would be set to June 5th. However, with the new system Enabled, that Credit Due Date will be shifted back to May 25th. That way when staff check off the event, it will be correctly dated, and fall into the correct reporting period for the NCI.
5. If the Protocol Data Page has enabled IRB Review History "Peek Through", when the IRB Dates of Review are displayed, the Memo is also Displayed (20 characters only).
6. On the Patient Photo Page, to the right of the "On Study Forms Completed (S0000) [x]" the study Disease Site is now displayed as a "Peek Thru".
7. There is a new feature in the Protocol Financials: Patient Milestone Overhead Percentages. The default value (%) can be set per protocol in the Financials Accruals Page. If there is a default percentage set, when Milestones are Collected, the dollar value for each patient event is calculated with the default percentage. The values can be edited on the fly. When an Invoice is Printed where a line item contains a dollar value for Overhead, there is a note to that effect on the Invoice Line: "Patient#12345: Scan - 06/10/2010 (Overhead $ 137.50 Included)" The event value to the right includes that dollar value.
IDEA:
1. See CREDIT items: 1, 6
IRBANA:
1. See CREDIT items: 2, 3, 5
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06/12/2010
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CREDIT:
1. There is a new link on the Prestudy Patient Data Page for Contact Date Workups: "Add New". Clicking the link pops up a new workup with an Undefined Protocol, Undefined Disease Site. When Saved, the popup closes and returns to the Prestudy Patient Data Page.
2. The Patient Protocol Arm Notes has been added as a column to include in the On\Off Study Report.
3. There 3 new macros that can be add into the Financials: Invoice Header.
@ProtoTitle
@BinderNumber
@CostCenter
4. There is a new Document Upload capability on the Patient Protocol "Data Management Log" in the Mini-Menu of the Patient Protocol Page. The Patient Document Upload Report has been modified to allow selection of this new Document Management feature.
5. There is now an option to have Protocol Arm Status changed when the Protocol Status changes. For this to be available, it must be Enabled in File Ops > System > System Variable Default Values > IRB Activities > When Protocol Status Changes, Echo Status to All Arms. Additionally, the Arms will only be automatically set to the Protocol Status if those Status types are select in the box above this new file Notify Staff on Protocol Status Change. For instance, if OPEN is selected for Staff Notification, and the new Echo Status feature is Enabled, when the protocol status changes from IRB Pending (or some other status) to OPEN, all Arms will be opened as well.
IDEA:
1. See CREDIT items: 5
IRBANA:
1. See CREDIT items:
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05/22/2010
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CREDIT:
1. There is a new column on the On\Off Study Report: Primary Care Physician. This pulls from the Patient Demographic page.
2. The Mail system now allows for Delete ALL & NONE links for automatic check box checking\unchecking.
3. The IRB Meeting Activity Summary now allows for pulling events by staff who logged IRB Events.
4. There is a new option to display the number of Prestudy Consents on the Protocol Data Page. For this option to be enabled, the System setting for "Show Accrual Count" must be enabled. Next to that System Variable Default Value is a new checkbox: "Show Consent Count". If the box is checked, whenever the Protocol data page is loaded, the number of Prestudy Consents will also be displayed.
5. The report "Patients by Staff" now includes the ability to select a "Location" if that field is enabled in the System setup.
6. The File Op > System > Notify Staff..... now allows for filtering the display page based on the existence of staff Email addresses loaded into the staff profiles.
7. The Patient Adverse Event page now supports the ability to have links to web sites displayed for convenient navigation. The links are to be entered in the File Ops > System > System Variable Default Values > Patient\Study section. Multiple links are to be separated by a comma. By default, 2 links have been provided and display on the patient adverse event page:
http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/Reverse_Mapping_CTCAE_4_to_CTCAE_3.xls
http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf
8. There is a new feature on the Financial Invoice\Payment page. If a payment is linked to additional studies, those studies are now clickable under the Check Number. The link loads the selected protocol, opens the financials, and loads the Payment Allocation Page for the check for allocating funds to the clicked protocol. There is an additional link at the top of the Allocation Page (if the check is for multiple studies), that will navigate to whatever protocol is listed as an alternate. This eliminates navigating out of, then into studies via the Protocol Search Engine when a check payment needs to be distributed over multiple studies.
9. The Patient Demographic Page now has "Apt/Suite #" as title to the second Street Address. The same field title is set in the Prestudy Patient Demographic page.
10. There is a new report under the Patient Section: "Patient Document Upload Report". It will pull the document titles for any documents uploaded behind the Patient Demographic pages (Photo Page). The report can be filtered by Hospital, Date, Uploading Staff.
11. When an IRB Document is uploaded, the system now captures the Staff and Date of Upload. There is a new report under the Protocols section to support this new feature: "Protocol Document Upload Report".
IDEA:
1. See CREDIT items: 1, 2, 5, 6, 7, 10
IRBANA:
1. See CREDIT items: 2, 3, 11
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05/01/2010
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CREDIT:
1. There is a new field available in the Protocol Review Log: Notation. The field does not follow any IRB pathways, it is intended as a local notation for staff reminders per the log entry.
2. The Patient by Events report now allows for pulling just the Next Event Due from patient calendars.
3. There is a new Financial Report: Revenue Report. It pulls all values for Milestones (invoiced or not), Direct Costs: Invoiced, Revisions: Invoiced, Revisions: Invoiced, SAEs: Invoiced, and Screen Failures: Invoiced. The report is Date Ranged and Protocol Specific.
4. There is a new Financial Report: Protocol Accounts Receivable. The report pulls all invoices and payments per Protocol and produces a Balance Due for each study. The report can be Ordered by Sponsor (the default) or by Protocol.
5. The Patient Adverse Event Page now allows for Printing\Word Exporting using the Documents Folders.
6. The Protocol Financial Patient Billing Module has been renamed: Financial Research Billing Compliance. The new name is more in keeping with the functionality of the module.
7. The Financial Research Billing Compliance Module now has a new Header Info similar to the Invoice Header. This Header is Department Specific and is only used in this Module. Previously this module used the Invoice Header.
8. IF there is an IRB Entry for the Patient AE, when you EDIT the Patient AE, it will automatically update the IRB Entry as well.
HOWEVER, if you change the IRB Entry it WILL NOT change the Patient AE Entry... so be very careful.
If Patient AE is changed, it updates the IRB AE.
Now, if a Regulatory Staff changes the IRB AE, it will not update the Patient AE.
So, if Patient Side Staff goes into the Patient AE and Edits it, whatever is on that page will reset the IRB AE.
This is pretty logical.... we do not want IRB staff changing Patient entries.
9. The Link Patients to Protocols Report now allows for Multiple Protocol Selection.
10. Patient Adverse Events can now have custom Questions be part of the entry. There is a new File Operation > Patients > Add Patient Adverse Event Question module that allows for Add\Edit\Delete of questions to be included on the Patient Adverse Event Module. The Questions should be numbered (1. ) for sorting order display on the AE Patient Page. Further, there is an new Macro for merging the Questions into a Form or Document (@AEQuestions). The Macro will pull the Question, Answer (Yes\No), and the Explanation if there is an entry for that Question. All Questions are listed via the Macro. Questions with an Answer of Yes or No will display that answer. Answers of "Unknown" will not display an answer via the Macro.
11. The Protocol Outstanding Issues Report can now be filtered by Investigator, Coordinator, Data Manager, or Protocol.
12. Most Popup Edit windows are now resizable.
13. When Editing a Patient Adverse Event, the Edit module is now a resizable popup window.
14. When Editing a Patient Adverse Event, the event can be "SAVED AS NEW ENTRY" (new button) and also allows for creating a parallel Regulatory Entry at the same time.
15. The Protocol Audit Report now allows for selecting the Summary Only.
16. The Document Processor now allows for Moving Folders. This is done in the "Add\Edit\Delete Folders" in the Mini-Menu.
IDEA:
1. See CREDIT items: 2, 3, 9, 10, 11, 12, 13, 14, 15, 16
IRBANA:
1. See CREDIT items: 1, 11, 12, 15, 16
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03/27/2010
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CREDIT:
1. When uploading an IRB Document, there has been a check box to Notify Staff (vial email) of the document. There s now an additional check box to Notify Research Team for the Protocol via email. For staff to be listed in the new check box link, they must be in the Research Team Log for the study, not have a resign date, and have an email address in their staff file.
2. There is a new Financial Report: "Invoice Account Line Items" that allows for pulling Invoices (date ranged) and select Hospital, Department, Protocol, Sponsor, and Account. The report also allows for Exporting to Excel for column sorting.
3. The Prestudy Listing Report can now be filtered by Disease Category.
4. There is a new "Find on this Page" link on the Protocol IRB: Adverse Event page. This facilitates locating an entry for editing or verifying that the entry exists or not.
5. There is a new Staff Access Control on the Protocol Monitor Visit Log. Staff who had access to the Review History Log (by default) have access to this new control. This can be modified per staff in each Staff Profile.
6. The Patient Adverse Event Acknowledgement Report is now interactive. Staff can check off the "Acknowledged" check box directly in the report.
7. The Protocol Status Report now allows filtering for "Confidentiality Agreement" if that option is Enabled in File Ops.
8. There is a new System Variable: Show Patient Arm Notes On Calendar Pages. By default it is Disabled. If Enabled, the Notes are displayed for Editing on the Cascade Range of Dates page in the patient-protocol section.
9. New Macros for Patient Adverse Events:
@AETreatmentDescription
@AEInvestigatorStatement
@AESuggestedChanges
10. The Deviation Log Report now includes 2 new Columns: Hospital & Date of Entry.
11. There is a new Financial Report : Payables: Account Line Items that allows for pulling Payables per Account Line Item over a Date Range.
12. The Prestudy Report now allows filtering by Eligibility Date.
13. The Patient Audit Log now allows for "N\A" as a check box for Compliant.
14. The Patient Audit Log Report now has the INTENSITY option of "Summary Only". In that mode, a summary table of Topics, Sub-Topics, and % Compliant is produced.
IDEA:
1. See CREDIT items: 1, 3, 6, 7, 8, 9, 10, 14
2. The Patient Arm-Notes now appear on the Dispense Page next to the Patient Photo.
3. The Drug Accountability Records can now be sorted by Actual Event Date via a new button at the bottom of the DAR.s
IRBANA:
1. See CREDIT items: 1, 4, 5, 7, 10
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03/06/2010
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CREDIT:
1. Internal Updates to optimize the System per SQL2005+ and ColdFusionMX7+
2. Protocol Adverse Events now includes the AE Grade *if* Extensive Reporting is enabled. The Grade is also populated from the Patient side when an entry is also created for the IRB. The Protocol Adverse Event Report also allows for Grade Selection as well as Sorting by Grade.
3. The Report of Staff Involvement now includes a filter and column for Staff Outstanding Issues (per Staff Profile Page).
4. The Principal Investigator Report now allows for Accrual Count as a column to include.
5. The Pre-Study List Report now allows for just pulling patients that have no Workups during a date range.
IDEA:
1. See CREDIT items: 1, 3
2. The Pharmacy DAR that is Patient Specific now has a "Running Inventory" column *if* the Drug for the Patient is Patient Specific.
3. In the File Operations > Pharmacy > Edit Pharmacy Environment Defaults, the Default "Treatment Window" now has the option of updating all existing protocols with the new value.
4. When Transporting Drugs to Component Institutions, the Drug List now defaults to only those agents involved with the Protocol. There is a link that will allow for all agents to be displayed.
5. On the Dispense Page, the Patient Protocol ID Number is now displayed under the Patient Photo.
IRBANA:
1. See CREDIT items: 1, 3
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02/13/2010
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CREDIT:
1. We continue to optimize CREDIT Page Loading. Page Load times have generally been improved by 100%-500%.
2. The Meeting Activity Reminder Report now allows filtering per Sponsor.
3. The Protocol Research Team now has the ability to capture the percent of effort for each member.
4. When a patient date of death is entered, and the protocol status for the patient protocols is updated to Deceased, the Status Change information is now captured as to which staff made the entry and on what date.
5. When a Financial Payment has been made, and the Check is assigned specifically to a protocol, that list of protocols can now be added to, check specific. There is a new link on the Payments Output Table under each Check #. The link is "Assigned To:". Clicking that link will allow for adding other protocols to the Check.
6. The IRB Meeting Activity Recorder now allows for changing the Protocol Version Date and the Current Consent Date while recording New Studies, Continuing Reviews, and Revisions. The Protocol Version Date and Current Consent Date must be enabled in the System Settings for this feature to be available.
7. The Pre-Study Report now has additional Memory Locations available. Staff can save the page selections to any number of "Defaults" using the Memory Location option.
8. There is a new Date field available in Prestudy Workups and Patient Protocols. HIPAA Consent Date is available on each Prestudy Protocol Workup. If the participant is Activated, the HIPAA Consent Date Value is passed to the Active Patient Protocol Page for that study. To enable this feature, the field must be Enabled via: File Ops > System > System Variable Default Values > Pre-Study > Show Prestudy HIPAA Consent Date
9. There is a new Date field in the Patient Audit Table: "Audit Complete Date". This field is now followed through the Add, Edit, Print, and Reports modules.
10. The Patient Audit Report now allows filtering by Sponsor. Additional columns have also been included: Audit Complete Date, Re-Audit Date, Patient Status, Location. The Date Range Selection also now allows for using the On-Study Date for the Patient.
11. When creating a Financial Invoice or Request for Payment, Patient Calendar Milestones are noted and colored RED if they have been Manually Entered Events by Staff (vs. CREDIT Generated per the Master Protocol Design).
12. There is a new feature in each Staff Profile that can allow the specific staff access to view other institution calendars from the Main Menu. By default, when the Hospital Calendar page is presented, the Staff "Home" hospital calendar is displayed. The "ALL Calendars" link at the top of the page allows for integrating all "Accessible" Calendars in one. This feature allows for staff to be limited to their own Hospital as far as general access to patients and protocols, but it opens up the window for them to share in the Hospital Calendar of others. The benefit here is to let staff from a component site share seeing your scheduled events (IRB Cut-off Dates, IRB Meetings, Monitors, Staff Out, etc...) without opening up Access for that Staff to other areas limited by that staff main Hospital Access.
13. The Staff Profile Page now includes a text box below the Licenses for "General Notes".
IDEA:
1. See CREDIT items: 1, 3, 4, 7, 8, 9, 10, 12, 13
2. Faster IDEA Startup Inspection of Inventory. When the first staff logs on each day, IDEA inspects for expiring agents, and sends mail to staff should any be found. That process was taking about 1-2 minutes each morning. The inspection time has now been reduced to about 10 seconds.
IRBANA:
1. See CREDIT items: 1, 2, 3, 6, 12, 13
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12/12/2009
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Special Notice Self-Hosting Sites, Effective 2/1/2010: (Duluth, Ochsner, Fargo, Gainesville, Phoenix, Grand Rapids) You will need to upgrade your Server to ColdFusionMX 8 or 9 as well as upgrade your SQL Server to 2008. Optionally you can elect to have InnerCircle Media (ICM) host your site (about $10 a day). ICM Maintains all upgrade hardware and software for your site at no additional charge.
CREDIT:
1. The Deviation Log now includes a new dropdown box for whether the event was Planned or not. The options are Yes, No, Unknown.
2. There is a new field in Patient and Protocol Adverse Events "Unanticipated", it is a simple check box. To support that field, there is a new macro that can be placed into the Adverse Event Form Template: @AEUnanticipated. That macro will return a value of either "Yes" or "No". This option can be enabled via File Ops > System > System Variable Default Values > Protocol IRB Activities > Show Protocol & Patient Adverse Event "Unanticipated Problem". For this feature to be Enabled, the system must also have Enabled " Use Extensive Protocol Adverse Event Recording" must also be Enabled. The new field is also available in Reports.
3. The "Protocol Links" page now allows for entry of email addresses as well as web sites.
4. There is a new feature in the Add\Edit Manual Events for Patients. A new button at the top of the page: "Show All Patients" will reload the page showing all patients on the protocol of the patient in use. By default a box is checked next to each patient name indicating that the event being added will also be added to the selected patient! By default patients who have an Off Study Date are not checked. Staff can check and uncheck boxes to indicate the list of patients who will receive the added entry. If the patients are all displayed, and staff wishes to only add for the patient in use, another button is available to "Simplify View", which reverts to the Single Patient Entry mode.
NOTE: Globally adding events to multiple patient calendars cannot be globally undone. Should staff need to remove events, it will need to be done inside of each patient calendar.
5. Patient Notification Creator: This system is meant to provide an easy way to "sync" your generated (merged) letters with an easy mechanism to "check off" that these letters have been sent (or received...etc). However, this is only one such application of the system. In general, it allows you to "tag" patients (or their specific studies) with an event. That event can then be "checked off" (such as a re-consent) by a user. In the future, once we've received feedback on the system, a reporting system will be created to allow for multi-processing.
To use the system, click the Patient Notification Creator link at the bottom of the Patients section of the Generate Reports page.
You can filter the patients by protocol, hospital (etc). Additionally, you can choose whether you want distinct patients or distinct patient studies. To briefly explain the difference, let's say that you want to send a letter to every patient that Dr. Smith is treating on any study to let the patient know that he is leaving the hospital. You would choose "distinct patients", since you wouldn't want to send multiple letters to the same patient in the instance that they are being treated by Dr. Smith on multiple studies. On the other side of the coin, let's say that you wanted to send a letter to inform the patient that they need to re-consent on their NSABP study (due to a regulation change). You may very well want to send multiple letters to patients who are on multiple NSABP studies informing them of each. For this, you would choose the "distinct patient protocols" option.
Depending on whether you have selected "patients" or "patient protocols", the checkbox will show up at the bottom of the patient page or the patient protocol page.
Once you give the notification a name (this is what will show up next to the checkbox on the patient page), you can submit.
The next page will show you all patients that qualify from your search criteria and an option to uncheck individual patients (or patient/protocols). It also is where you will choose whether or not to create a merge file with the patients for letter generation via the Document Processor.
Additionally, there is the ability to expand upon the simple checkbox.
Let's say that, in addition to having a checkbox for a Re-consent, you would like to capture the date that the letter was sent, the date the re-consent occurred, and a memo for additional information. We have created a mechanism that allows you to create your own fields!
So, in the case of our example above, you could create a "Date" field called "Re-consent Letter Sent Date", a "Date" field called "Received Letter Acknowledged Date" and a "Text" field called "Re-consent Letter Notes".
You can also specify whether that field must be filled out by the user by making it required.
Once you submit the page, it will automatically add those checkbox (and user created fields) to the patient (or patient protocol) page. It will also create the merge file, if chosen, which can immediately be accessed in the Documents area to generate letters.
6. If the Medical Location for patients is enabled, the Prestudy Screening Workup now will have that option as a selection.
7. The Prestudy Listing Report now includes Medical Location as a filtering tool as well as a column to include.
8. The Financial Report "Invoice Aging" now allows for showing the Protocol DETAILS of the aged invoice. This mode is only supported when a single Protocol is chosen. The link to expand the invoices (displays line item within the invoice) is a simple link in the upper right corner of the Report page (once the report has been run) "Show Details". If the detailed invoice view is enabled, the link changes to "Simplify View" to revert to the original report display.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7
2. The Pharmacy Report: "Patients by Lot#" now includes an inspection of Inventory. Previously it only inspected Dispenses.
3. On Patient Specific Drug Order Forms the Current Inventory is now limited to the Inventory on Hand for the Specific Patient the order is for.
IRBANA:
1. See CREDIT items: 1, 2, 3
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11/26/2009
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Special Note: You may notice many of your pages and reports running very quickly. We have been dedicating a lot of energy in re-writing many of the web pages in CREDIT, IDEA, and IRBANA. The objective is to shave off as much time as possible to help you work more efficiently! We have recently purchased another 3rd party software system that analyzes all aspects of your Web Site. That data gleaned from your site has translated into a more efficient page management on your local computer! The DDOTS staff is dedicated to keeping all systems on the edge of "State-of-Art".
Special Notice Self-Hosting Sites, Effective 2/1/2010: (Duluth, Ochsner, Fargo, Gainesville, Phoenix) You will need to upgrade your Server to ColdFusionMX 8 or 9 as well as upgrade your SQL Server to 2008. Optionally you can elect to have InnerCircle Media (ICM) host your site (about $10 a day). ICM Maintains all upgrade software for your site at no additional charge.
CREDIT:
1. The Projected Revenues Report now breaks out the Patient Milestone column into "Competed" and "Not Completed" (or Earned and Not Earned). Further it includes a column for amount paid on the Patient Milestones.
2. There are 2 new Document Upload Modules in the Financial System: "Direct Costs" and "Request For Payment". Files can now be uploaded for each item listed on the pages.
3. We have expanded the IRB:Documents section by allowing the individual
documents to be "attached" to a regulatory event (or multiple regulatory events).
You can, at any time, go into the IRB Documents area and "tag" the file as being
related to any regulatory event for that protocol.
Additionally, you can upload a document (or multiple documents) at the time that
you are creating the regulatory event. To do this, you press the 'Browse' button and
select a file. You must then include a "Valid As Of" date and, optionally, an
expiration date. When you Save the new regulatory event, it will automatically
put the files into the IRB Documents area and tag them for that regulatory event.
In fact, if you have multiple IRBs and you choose those additional IRBs to receive
the regulatory event, the document will get copied over into those IRBs as well!
If you edit/view a previous regulatory event, you will see a list of all documents that
are tagged to that regulatory event. You may click the checkbox next to any that
you'd like to unattach and save it. Note: it does not delete the file! It remains in
the IRB Documents area. However, it is no longer attached to the regulatory event.
While in edit/view mode, you may also attach new files from you hard drive, which
works exactly as it does when you are first creating the regulatory event, with the
exception that it only adds the document for that specific IRB.
In the near future we will be making the documents "linkable"' so that you can view
them from the page that you are on. Additionally, we intend to create some reporting
mechanisms. From there, however, we are relying on our vast base of CREDIT and
IRBANA users to let us know how this new functionality could be improved and how
it could best serve their specific needs.
4. There are several new macros that can be used in Merging IRB Regulatory Documents:
@SuspendedDate
@RestartDate
@ClosedDate
@TerminationDate
5. The Link Patients & Protocols report now allows for Ordering by the Protocol PI and the Protocol PI is also a Column to Include.
6. The Patient "Hospital ID Number" can now be Required. This is managed via File Ops > System > System Variable Default Values > Patient\Study: Patient Hospital ID Title Identifier: Required
IDEA:
1. See CREDIT items: 4, 5, 6
2. When Pre-Populating Drugs, if the inventory is Patient Specific, the Patient Selection Box now also includes the Patient Protocol ID.
3. The Patient DAR now has a new table at the bottom: Patient Specific Inventory for (Patient Name).
IRBANA:
1. See CREDIT items: 4
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10/31/2009
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CREDIT:
1. There is a new "Account Number" System in place for assigning Invoice Line Items and Payable Line Items to specific accounts. To facilitate this process, there are 3 new File Ops:
Add Financial Line Item Account
Edit Financial Line Item Account
Delete Financial Line Item Account
Then, each line item for each Invoice can be associated with a specific account. There are no reports as of this time to support this new feature, as they will be constructed in a future updater.
2. The ORC Recordings for each Protocol now allows for Uploading Documents.
3. Prestudy Workup Notes are now carried over to the Patient Protocol Notepad when the Prestudy Patient is Activated.
4. Objective: Build a set of Protocol Default Regulatory Submissions for pre-loading behind a new protocol to save staff time from loading one-at-a-time.
On the Protocol Side of things, in the Mini-Menu > Regulatory Submission Log, a set of Default Submissions can be loaded. For this feature to show up, the Submission Log must be empty to start. Also, in File Operations > Protocols > Edit Submissions for Protocols each entry has the ability to be tagged as a "Default Form". Default Forms are then linked to the "Load Defaults" link on the protocol side of things. When the Load Defaults is activated, a window pops up with all of the Default Forms displayed. All Date Entries are defaulted to "Today", and boxes are checked to indicate which Submissions should be loaded upon Save.
5. The Financial Patient Billing page now has a Date Field for each Line Item entry.
6. The Patient Billing Log now allows for the selection of a Vendor.
7. The Financial Direct Payables now allows for Document Upload per Direct Payable Line Item.
IDEA:
1. See CREDIT items: 2, 3, 4, 5, 6, 7
IRBANA:
1. See CREDIT items: 4
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10/17/2009
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CREDIT:
1. The Staff Profile page now includes a NOTES field.
2. All Archive Systems (Patient, Patient Protocol, & Protocol) now have an "Archive Location #2" and "Archive Notes".
3. For the Financial Patient Billing Module, default Email Selections can now be set. File Ops > System > System Variable Default Values > Financials. The Staff selected as defaults will automatically populate in the Patient Billing Module to receive the Email Notification.
4. The Report Protocols per Department now allows filtering per Protocol Type.
5. There is a new Protocol Report for Monitor Visits.
6. The Protocol Adverse Event Report now has 4 slots for entering Search Words. The target of the search is the AE Memo field. Fort Collins, CO plans on entering in the IRB Protocol IDs into that field for every study the AE is assigned to. With this tool, they can then use the Report to pull all SAEs that contain the desired Protocol ID.
7. For Patient Document Uploads in the IRB Module for each study the "Valid for Use" date defaults to Today. Now there is a link next to the date to load the "Next IRB Meeting Date" into the date field.
IDEA:
1. See CREDIT items: 1, 2, 3, 5, 6
IRBANA:
1. See CREDIT items: 1, 2, 3, 5, 6, 7
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09/19/2009
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CREDIT:
1. The IRB Follow-Up sheets now allows for Disabling the Research Team from the bottom of the listing. This is done via File Ops > IRB > IRB Meeting Environmental Defaults >: #32 Show Research Team on IRB Follow-Up Sheets
2. The Default Status for adding in a new study can now be set In File Ops > System > System Variable Default Values > (Second to Last entry in the Protocol Data section) "When a New Protocol is Added, Set Status to:"
3. There is a new optional field on the Protocol Data page: "Data & Safety Monitor Board". To enable: File Ops > System > System Variable Default Values > (Second to Last entry in the Protocol Data section) " Show Protocol Data & Safety Monitor Board".
By default it is Disabled, and these entries have been pre-loaded:
Study will use local DSMB
Study sponsor will provide DSMB (Industry Sponsored)
Study sponsor will provide DSMB (Cooperative Group)
N/A - DSMB oversight is not required
The values may be Added\Edited in File Ops > Protocol > Monitor Board
4. There is a new feature that allows (per protocol) staff to be notified when patients have a birthday that has been set in the Protocol Data page. The initiative for this feature was to allow staff to be emailed a notice when patients turn the age of 18, when re-consenting may be required. The new feature is located below the listing of Ancillary Studies on each Protocol Data Page, and is Protocol Specific.
5. The Report > Patients > Auxiliary Doctors now includes the Registering Doctor as well as the Auxiliary Doctors. Further, it has the ability to capture earned NCI CCOP Credits (if you are an NCI CCOP) as a Column to Include.
IDEA:
1. See CREDIT items: 1, 2, 3, 4
IRBANA:
1. See CREDIT items: 1, 2, 3
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08/29/2009
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CREDIT:
1. The Prestudy Patient Report now includes the ability to filter by Ethnicity and\or Ethnic Category.
2. There is a new Staff Access capability for Patient Deviations. Staff who already have access to Patient Assignment to Protocol will automatically be defaulted to access to the Patient Deviation Log. Access may be changed per staff in each staff profile.
3. In Prestudy, each Workup can now have Auxiliary Doctors attached. Then, when the patient is Activated to the study, those Docs are automatically loaded into the Patient Protocol Module.
4. The Protocol Research Team has been added to the Protocol IRB Follow-Up Sheets.
5. There is a new module in the Protocol Regulatory Mini-Menu: "Monitor Visit Log". The page allows for logging the time of day the monitor visited, the duration of the visit, a memo, and document uploading for scanned reports from the Monitor. When in EDIT mode, additional documents can be uploaded into the single event.
6. If Show the Reason for Death is enabled, the Patient\Protocol page now requires the reason be selected if the date of death is entered.
7. The Report Module now allows for tagging specific reports as "Favorites". Each report link has a "heart" associated with it. By default, the hearts are gray. However, clicking directly on the heart will change it to red. This will allow users to customize the report page highlighting the reports they most often use.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7
IRBANA:
1. See CREDIT items: 4, 5, 7
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08/15/2009
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CREDIT:
1. The Report "View Patients by Staff" has a new column to include: Next Patient Due Date. The date pulled is the next calendar event for the patient that is due to be done.
2. There is a new Protocol Report: Protocols By Department.
3. The Protocol Status Report, Notepad Format is now available.
4. The Link Patients and Protocols Report has a new column: Current Protocol Status
5. The Report On\Off Study now has the ability for Multi-Select Protocols vs. Single Select Protocol
6. If the System Default for Show Accrual Association Membership is Enabled, a new column is now available in the On\Off Study Report: "Accrual Association".
7. When printing the Protocol Follow-up Sheets for IRB Submission, each Log has it's own paging and letterhead. There is now a new feature that allows for the Logs to print without ejecting pages between logs. This option also eliminates redundant letterhead space on each page. The path to enable this new feature is:
File Ops > System > System Variable Default Values > Protocol IRB Activities > Protocol IRB Follow-up Sheet Paging: No Page Breaks Per Log.
8. The Financial Report: "Cash Receipts Journal" now allows for filtering by Payments Received that have never been Allocated.
9. The Protocol Status Report now includes Patient Counts.
10. The Protocol Financials "Requests for Payment" (RFP) can now have the Service Provider the various component institutions involved with the research for the main institution. These component sites can be the selected Service Provider for a specific Request for Payment. The organization that requested this option currently pays the component sites per accrual and for follow-up. This process allows for that to be managed within CREDIT with a minimum of effort.
For example, Hospital A accrues 20 patient to 10 different protocols over a 3 month period. Hospital B accrues 15 patients to 6 different protocols over the same period. How can we keep track of what we should be paying Hospital A and Hospital B? In the Reports Module, there is a new report "Request for Payment Generator" that will allow for creating separate RFPs for each Hospital for each Protocol. That way Hospital A will have 10 RFPs for the date range. Hospital B will have 6 RFPs for the date range.
Then, there is another report which will pull all the RFPs for a selected Hospital, date ranged. That way, the specific RFPs get listed with total payment amounts. Finally, there is a link on the Report Output Screen to SHOW DETAILS. That pops up a window with every entry for every RFP for that Hospital, ready for printing.
11. The Time Task Manager is now available from the Prestudy Patient Workup Page.
12. There is a new Automatic Email Notification capability for Patient Adverse Events. Selected Staff need to be added to the Notification List via File Ops > System > Staff Notifications. The far right column is for "Email Pat. Adverse Events". The column will be pink if the staff does *not* have an email address in their profile. When all selected staff are checked for the notification, they can receive an Internet Email when a patient AE is logged. The Email Filter is per Institution and Department defined by the staff profile of the recipient of the email.
To facilitate whether or not to send the emails, there is a new checkbox on the Patient AE Entry Page: "Email Staff". By default it is checked *if* there are any staff set to be notified. Further, the words "Email Staff" are linked if there are staff to be notified. Clicking on the link pops up the list of staff who will be notified.
The Emails are automatically send when the new AE is Saved.
13. The Patient Master Schedule Report now allows for the Exclusion of Financial Events where there has already been a "Request for Payment" on the calendar event.
14. When Loading the Default Research Team Members (only available when there are no existing members for the study, AND some staff have their "Contact Type" set in their profiles), the popup list is now filtered per Department Authorization. This is key. Each potential member needs to have their Departments and Hospitals checked in their staff profile. Otherwise they will not show up on the list for inclusion. The list for Loading Defaults is filtered per the Department and Institution for the specific study.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 14
IRBANA:
1. See CREDIT items: 2, 14
2. The Meeting Activity Recorder now allows for Date Changes (from the Meeting Date to some other date), such that Expedited Reviews can be bulk recorded.
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08/01/2009
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CREDIT:
1. The Protocol Research Team page now has a notepad text box.
2. The Protocol Data Page has the default 3 Research Team Members names displayed. Additional Contact Types can now be added to the page via File Ops > System > System Variable Default Values > Protocol Data > Protocol Data Page Research Staff Peek-Throughs.
3. Prestudy Patient Workups now have the ability to create a Patient Requisition. The link is below the ACTIVATE button that is associated with the Patient and Protocol. Requisitions are not available for studies that are Closed, nor for Workups that have no defined protocol.
4. There is a new Status available for setting in the Financials Module. The selection is made on the Financial Accruals page in the Financial Module for each Protocol. If a Financial Status is set, the status peeks through at the top of the Protocol Data Page. Financial Status are managed in File Ops > Protocols > Edit Financial Status for Protocol.
5. The Protocol Report: "Events by Protocol" now allows for filtering for specific key words.
6. The Protocol Financial Request for Payment (RFP) "Service Provider" is now coupled with another dropdown of "Patients" on the study. A selection can now be made from either one for attachment to the RFP.
7. There is a new Financial Patient Billing Module now available in the Financials Module for each protocol. CPT Codes and Names as well as Order Category are populated via File Operations > Protocols > Add\Edit\Delete Patient Billing Code & Add\Edit\Delete Patient Billing Category. The new Billing Module is designed as a system to assist in avoiding double billing. It will also send out email notifications to selected staff and include the billing information.
8. Financial Invoices are now populated with the Sponsor (or Payor) Email address. The new field is available for populating when EDIT Payor is popped up for changing information. The Email address is Protocol Specific for each Payor.
9. If the Patient Financial Payment Source is set to Required, and a Prestudy Patient is Activated on a study, the Popup Arm Selection Box will evaluate if there has been a selection made for that field in Prestudy. If *not*, the Financial Payment Source selection box appears and will not allow the Save button to Continue unless a selection is made. Once a selection has been made, that entry is saved in Prestudy for the Patient as well as in the Active Patient Entry on the Patient Data (Photo) Page.
10. The Prestudy Patient Report now has a new column available: Screening ID Number.
11. The Protocol Current Status Report now has IRB Review Dates available as Columns to Include.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 9, 10, 11
IRBANA:<.b>
1. See CREDIT items: 1, 2, 11
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07/18/2009
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CREDIT:
1. For those with Financials Enabled, there is a new feature that allows Payment Holdbacks to be applied when payments are made. The setup begins on the Financials "Accruals" page. At the bottom of the page, the user is prompted to list the contracted Holdback Percentages "10,20" become "10%, 20%" respectively. Then when the Payments are being Allocated to events, those 2 additional buttons will appear with the $ values and the % value. So, if an event is Invoiced for $100, the first allocation button is "$100.00". The next button is "$90.00 (-10%)", and the last button is "$80.00 (-20)". Simply clicking the correct button loads that value directly into the input payment field... no more hand calculating is needed!
2. For those with Financials Enabled, there is a new Document Upload feature for each Invoice. After an Invoice has been created, the Invoice # is linked to popup a new window to manage multiple document upload and downloads associated with that specific invoice. So, if there are submissions that the sponsor requires accompany an invoice, those documents can be scanned and uploaded for easy retrieval should reprinting or auditing demand.
3. The new Protocol Status Report has been drastically modified and simplified. Many columns that were unrelated to the protocol "Status" have been removed. Should staff need new columns, they may request them, however, it may require DDOTS creating a new report rather than clutter up the new clean Status Report.
4. When the Protocol Status Report output screen is generated, there is an evaluation made about "Registration Allowed" for the protocol & institution. If the feature "Show Regulatory Registration Capability on Data Page" is enabled in the System, then the Status Report Output will have a Strike-out line through the Study ID, and the words "Registration Prohibited" are displayed under the ID. This feature is Institution Specific.
5. When an Off Treatment Date is entered, staff is now alerted to the Ignoring of future Drug events and is allowed to Cancel the entry. Prior to this modification, the staff was simply notified and the save was executed anyway.
6. The Financial Projected Receivables now has a Date Range (Start & End). When the report is generated, the Patient Milestones $ Value is linked to a popup. The Popup lists the Patients and Events that make up the total Projection for the specific Protocol.
7. On the Patient Protocol Page, there is a new "Date of Death" entry below the Patient Status. This is to help staff remember to put that date into CREDIT. The Date is the same data point as the Date of Death on the patient "Photo Page".
8. There are new links on (and inside) of the Patient Protocol Page: "Print DOCUMENT Word". The words Print and Word are linked to the Documents Module where any stored Templates can be Merged per the Patient Protocol Data. There are Patient, Protocol, and Patient Protocol Macros available for loading into any template that will pull the data and populate. The Print link simply creates the Template output on the Screen for immediate printing, while the Word link pops up the merged document into Word for Windows for Saving and further Editing.
9. The Protocol Current Status Report continues to be rebuilt. As you need to have features added that have been removed, please email your request.
IDEA:
1. See CREDIT items: 4, 5, 6, 7, 8, 9
IRBANA:
1. See CREDIT items:
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07/05/2009
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CREDIT:
1. For protocols that have financials enabled, there is a new feature that allows for uploading scanned payment checks. Each check number is now linked. When clicked, a popup window appears allowing the user to browse and locate the scanned check. When saved, the popup window closes and the main invoice\payment page reloads with a small check image to the left of that entry. Clicking on the image allows for OPEN, REMOVE, or REPLACEing.
2. The Financial Report: Invoice Register now has Invoice # links that popup the details (print view) of the invoice listed.
3. If there are actual Certificate Documents uploaded for the Institution, there is now a new link under each Protocol > Mini Menu > Submissions. The button "Certificates" will popup a window that holds those links do download and\or open the certificates listed.
4. The Protocol Submissions Module now allows for uploading a document associated with every submission. The document can also be managed via "Open, Remove, Replace" with a popup by clicking on the name of the submission Document.
5. There is a new field in the Financials Payee Information Popup: Purchase Order Number. The field prints on the Invoice, last line in the REMIT TO: box.
6. The patient photo page allows for uploading a photo of the patient. Now, a new feature (which must be enabled to use it) allows for uploading a scanned Patient ID Card. Any scanned image (Drivers License, Photo ID, Passport Page, etc...) can be uploaded.
7. The Patient Protocol Page Toolbox (Mini-Menu) now contains other protocols that the patient is on. This eliminates the need for going to the Photo Page again to migrate into other studies for the patient. Additionally, if an ID Card has been uploaded, it will display on the Toolbox. Further, the image displays are linked to quickly load the Patient Data (Photo Page) without using the Mini-Menu option to get there.
IDEA:
1. See CREDIT items: 3, 4, 6, 7
IRBANA:
1. See CREDIT items: 3, 4
2. The Protocol Status is controlled by the most recent IRB Log entry (History or Revisions), and is not allowed to be changed on the Protocol Data Page. For those who would like the ability to make the status change directly on the protocol data page, that capability is now available. The System setting "Protocol Status Change via" (Automatic: per most recent Regulatory Entry) or (Manual: per Staff on Data Page). The default is Automatic to maintain the historical method of Status Settings. If the setting is set to Manual, IRBANA will no longer evaluate the IRB entries and set the status on the Data Page. Manual setting becomes the responisibility of Staff to make the change by hand. Also note, the Meeting Activity Recorder for New Studies, Continuing Reviews, and Revisions have the ability to change the Status on the Protocol Data Page. Changing the Status while recording meeting activities *will* change the status on the Protocol Data Page.
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06/06/2009
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CREDIT:
1. The Patient Data Page will now display a large black box with "DECEASED" in it next to the photo if, in fact, the patient has a Date of Death.
2. The IRB Reseach Team members now will display a link to "Licenses" if, in fact, the staff has licenses listed in the Staff Profile. The link pops up a listing of the licenses for that staff.
3. A button to launch the "Time-Task Recorder" is now on the Protocol Data Page.
4. There has been a major change to the Regulatory Modules. Prior to this update, each Institution could only have One IRB. That has now changed so any given Institution (including and IRB Institution) can have multiple IRBs they are using. This is particularly helpful for Institutions that have Central IRBs processing submissions. Multiple IRBs can be added on each Institution Data Page via File Ops.
5. The Report On\Off Study now has an addition to the Column On Study Date. Patient Age at On Study is a checkbox that can be included in the column. If that choice is made, there is a summary table included that indicates the number of patients at specific ages.
6. Each staff can have an alert put into their Staff Profile for echo on the Protocol Research Team Page. Then, when selecting that staff for adding to a Research Team, that flag information comes up.
7. When a new Protocol Shell is entered, the Principal Investigator can now be loaded (and will be required) on the New Study Data Entry Page. This is a new System Setting "When a New Study is Added, Require Principal Investigator", and by default it is Disabled, which is the environment prior to this update.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7
IRBANA:
1. See CREDIT items: 2, 4, 6
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05/09/2009
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CREDIT:
1. There is a new "IRB of Record" system that has been installed. This will take some time to explain, so
When we examine how an institution is attached to an IRB, we can see how a new system was needed.
Consider that an institution has several “components (children)” that are reliant on the “mother” institution for IRB activity. When Mom submits a study for annual review, it does so also on behalf of the “Children”. That all works perfectly.
Now consider if the Mother institution has a CIRB review the study. Really, that is a different institution than the normal. So what we now have is the Mother has multiple institutions that can be flagged for “who does the reviews”. This breaks the straight line association of Institution IRB to Mother to Children.
In the past we allowed for staff to simply type in the IRB of Record. But, we noted that the Children were still looking to the Mom IRB for association. In reality, when Mom used the CIRB, it was the CIRB that the Kids should have been associated with.
The new system allows for this convention. Those institutions that desire to enable this “Automatic” association of a study to a CIRB, including mom and the kids, will need to add a new Institution (Hospital) in File Ops > IRB > Add Hospital\Institution (Central IRB… CIRB). Hold it right there… do not do this *yet*!
*IF* you do the above, you will need to give all logon staff who manage protocols access to this new institution. You will also need to go into the Mom Hospital (Edit Hospital) and check the new box to allow mom to have a… well… Mom… the new CIRB.
Having done that, each protocol that has a CIRB (or other… you will need to add them all in as Institutions), will need to have *that* Component have Access to the study, and have a status set. IRB Meeting Dates for these CIRBs will also need to be loaded. It is recommended that the “Local” Meeting Dates be loaded for all CIRBs. When this is done, on the Mom Protocol Data page, the single line display for IRB of Record will become a dropdown box. Then, Mom can select “CIRB” from the dropdown box for that study.
Appropriately, then, all CIRB Regulatory entries *should* be housed under the new CIRB institution. And, all *other* External IRBs will do the same.
The above explanation offers a true capacity to separate out the Regulatory per reviewing agency. Now for the option.
IF you are not interested in going in the direction outlined above, you can still manage IRB of Record from a simple dropdown box. In File Ops > System > System Variable Default Values > Method of Selection for IRB of Record Display.
The options are for Automatic vs. Manual. The default is Automatic. Change it to Manual and Save. Now the Protocol Data Pages will contain all the original hand entered CIRBs. You may discover several that mean the same thing, but were mistakenly typed incorrectly in various studies. Hence, File Ops > Protocol > Add\Edit\Delete IRB of Record.
In the new File Ops, one can Edit an IRB of Record they wish to delete. You cannot delete an IRB of Record unless it is not attached to any study. So, the Edit mode has “Show Attachments” button in the upper left corner. You will need to print those attachments out so that you can open the studies and re-assign to some other CIRB entry. When all associations are cleared, you will be able to File Ops > Protocols > Delete IRB of Record.
Note that the above (Manual) option allows for all regulatory to be housed under one institution (even though other CIRBs are actually doing the reviews). Additionally, the Manual system eliminates future typos for CIRBs as it is a dropdown box instead of a simple text box.
If your institution decides to follow through on the Automatic IRB of Record rather than switching to Manual IRB of Record, you may want to “Move Regulatory” logs from your institution to the CIRB institution. IF you decide to do this (and you are not required to do so), there is a File Ops > System > System Variable…. > IRB > Allow Regulatory Logs to Migrate from One IRB to Another
If this is “Enabled” (default is Disabled), a button will appear on the Protocol Data page (top left) “Move Regulatory”. This button allows for moving all logged entries over to another IRB. This should *only* be done if the intention is to maintain multiple IRBs in the system.
In a nutshell, if you want to manually manage your CIRBs, you will need to select that feature in File Ops as noted above. Otherwise, you will only have one true IRB (and no dropdown box) for assignment per protocol.
IDEA:
1. See CREDIT items: 1
IRBANA:
1. See CREDIT items: 1
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04/18/2009
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CREDIT:
1. The Report to Link Patients & Protocols now allows for bulk updating of Patient Status on Protocol. First of all, the Column "Patient Protocol Status" must be checked. The, to the right of that box is another option: Allow Status Change. Checking that box makes the output report interactive in that staff can change each patient status in the listing.
2. Protocol Form Uploads and IRB Document Uploads now have a "Notes" field.
3. Staff Notifications of a New Accrual now includes the Study Coordinator and the Patient Investigator.
4. When Archiving a Protocol, the Systems have always allowed for Auto-Archive Patients. There is an updated environment that allows for selection of patient for archiving as well as patient\protocol archiving for the selected protocol. Further, each entry can have a unique Archive Location. If the Protocol is set to DESTROYED, the patient records that are set to Archive will also get a Destroyed Flag and the Destroy Date.
5. The Patient Protocol Page now includes an "Absolute Neutrophil Count" Calculator along with the BSA Calculator. For this option to display, it must be Enabled via File Ops > System > System Variable Default Values > Show Patient "Absolute Neutrophil Count" (ANC). By default, this feature is Disabled.
6. In the File Op > Staff > Edit Staff & Assignments, the popup button to SHOW ATTACHMENTS now includes entries in the Protocol Research Team Log. If a staff is selected to Replace the existing staff, in the Team Log the old staff gets today as the Resigned Date, and the newly selected Staff is added to the protocol team log. As expected, the entries are Protocol Specific in the popup page.
7. When entering auto comments in the patient check-off area, you can now select to have the comment only impact the non-completed items.
8. The BSA Calculator can now calculate patient Dose.
9. Prestudy Patient Workups now have 2 new dates: Screen Date, and Surgery Date.
10. There is a new report to complement the Staff Productivity Report. The new Protocol Productivity Report will pull all Patient Completed Events for a Date Range per Protocol. It is a Summary report and is sorted by Protocol ID.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7, 8, 9
IRBANA:
1. See CREDIT items: 2, 6
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04/04/2009
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CREDIT:
1. The Report to Link Patients & Protocols now allows for bulk updating of Patient Status on Protocol. First of all, the Column "Patient Protocol Status" must be checked. The, to the right of that box is another option: Allow Status Change. Checking that box makes the output report interactive in that staff can change each patient status in the listing.
2. Protocol Form Uploads and IRB Document Uploads now have a "Notes" field.
3. Staff Notifications of a New Accrual now includes the Study Coordinator and the Patient Investigator.
4. When Archiving a Protocol, the Systems have always allowed for Auto-Archive Patients. There is an updated environment that allows for selection of patient for archiving as well as patient\protocol archiving for the selected protocol. Further, each entry can have a unique Archive Location. If the Protocol is set to DESTROYED, the patient records that are set to Archive will also get a Destroyed Flag and the Destroy Date.
IDEA:
1. See CREDIT items: 1, 2, 3, 4
IRBANA:
1. See CREDIT items: 2
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03/07/2009
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CREDIT:
1. The Protocol Document Uploading with Staff Notification is now an optional feature. Previously, every uploaded document triggered staff notification. Now, a checkbox has been placed next to the button to upload: Notify Staff.
2. Each Hospital\Institution can now have a default "Color" to help staff identify which hospital they are working in with protocols and regulatory. The default color is the existing CREDIT Toolbox Color, and it is the Toolbox that changes color with the institution. To change the color for a hospital, File Ops > IRB > Edit Hospital\Institution. At the bottom of the page is a color bar and link to change the color. A popup appears with over 400 colors to choose from.
3. The Report On\Off Study now includes the ability to Filter by Patient Financial Payment Source. It can be sorted on the field as well as included as a column.
4. The NCI CCOP report now have Form 2590 (Inclusion Enrollment Report Form) in Summary Format. Prior to this update, each Protocol had an individual page. Also note (from the NCI), you should never submit individual pages. They are for your information only. Further, you should ONLY submit the Summary Page for Grant Renewals! The Summary Page is *not* to be included in your periodic reporting through the year.
5. When entering the Patient Module, multiple institution installations are prompted to choose the Institution. When you edit (or add) a patient, and assign the "Originating Hospital Institution", upon saving, the Toolbar at the bottom will be changed to the page selected institution. This is also true on the Patient Protocol Page. Whatever that institution is set to on that page, the Toolbox will reload with that institution.
6. The Financial Protocol Specific Report now includes Requests for Payments associated with the protocol data that is displayed (Invoices and Payments made).
7. The Time Task Recorder now has a button on the Patient Protocol Page to facilitate logging Protocol Specific Time for management purposes.
IDEA:
1. See CREDIT items: 1, 2, 3, 5
IRBANA:
1. See CREDIT items: 1, 2
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02/21/2009
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CREDIT:
1. The Patient Consent Form Log now allows for User Adding for Patient Reconsenting.
2. The Patient Data Management Report can now be sorted by Location.
3. The Prestudy Patient Listing Report now has a memory to recall the last settings for a given staff.
4. The Patient Protocol Alternate ID #1 & #2 fields can now be set to "Required" via File Ops > System > System Variable Default Values.
5. The Staff Information Report can now be filtered per Staff Capability: Referring and\or Accruing.
6. The Link Patients & Protocols report now allows for filtering patients On Treatment or Off Treatment.
7. The Prestudy Patient Data page now has Allergies and Home Meds boxes available. They only appear if ENABLED in File Operations for the Patient Data Page. When the Patient is Activated, any data from the new prestudy data fields are copied over to the Patient Photo Page.
8. Prestudy now has the Alternate Contact Fields installed. These, too, will migrate to the Patient Photo Page when the patient is Activated.
9. The Patient Mailing Label Report can now be Exported to a Text (comma delimited) file that will launch Excel and load it with the data. This, of course, is only possible if you have Excel loaded on you PC.
10. The Protocol Recent Consent Date is now displayed on the Protocol Follow-up Sheet, Page 1. Of course, the field must be Enabled in File Ops > System > System Variable Default Values for this feature to function.
11. When the Continuing Review Report is run, the bottom left button on the outpage now allows for printing the SELECTED entries Follow-Up Sheets. By default, they are all selected. Additionally, specific pages of the Sheets can be specified via check boxes. If there are any entires that are "Sent to IRB" those Follow-up Sheets can be printed via a new button -Follow-Up Documents: "Sent"-
12. If the Prestudy Patient Demographic Disease Site field is enabled in File Ops > System, that column will be selectable in the Pre-Study Listing Report.
13. The Staff Information Report (General) can now be ordered by Hospital.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13
IRBANA:
1. See CREDIT items: 10, 11, 13
2. There is a new Editor in place for the Agenda & Minutes.
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01/31/2009
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CREDIT:
1. The new Patient Requisitions (Updater 1/24/2009) now has a button to "Add" a new event to the Event List for Requesting.
2. The Meeting Activity Recorder now has a new column to include (if it is enabled in the System) "Submission Received Date".
IDEA:
1. See CREDIT items: 1, 2
IRBANA:
1. See CREDIT items: 2
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01/24/2009
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CREDIT:
1. When a date of death is entered and the Reason Off-Study is enabled, that reason can be set to a default value. File Ops > System > System Variable Default Values > Patient/Study > When Patient Death Date is Entered, Set Patient Status to:
2. The Patient Financial Payment Source can now be made Required. File Ops > System > System Variable Default Values > Patient/Study > Patient Financial Payment Source Required.
3. There is a new Patient Requisition Module that allows for events to be "Ordered" from Service Providers. These include Labs, Drugs, and other Activities. Under each Patient "Event Focus" page (calendars), is a new option in the Mini-Menu "Patient Requisitions". By going to this new page there will be listed various fileds to fill in as well as a complete list of distinct "Events" that make up the patient calendar on that specific study. There are also "Filling Agencies" that can be selected for each event (Laboratory, Ancillary Services, Radiology, etc...). (There is also a complete set of File Operations to support Add\Edit\Delete Patient Requisition Filling Agencies, located at the bottom of the Patient section.) The Requisition can be Saved and Printed. For Editing, the Requisition "#" is linked for popup editing\deleting\printing. Additionally on the main Requisition page is a button (upper right) for "Header Info". This button will popup the editor and allow for creating header information that will be placed at the top of the printed Requisition. An example might be:
-------------------------------------------------------------------------------
Decatur Memorial Hospital
Clinical Research Requisition
The patient named below is NOT RESPONSIBLE for this bill. The patient is a research study participant. Please charge the Charge Account indicated below to receive payment for procedures requested by the Clinical Research Associate (CRA). For questions, please call Clinical Research at xxx-xx-xxxx.
-------------------------------------------------------------------------------
4. The Link Patients & Protocols report now includes a column for Patient\Protocol Notes.
IDEA:
1. See CREDIT items: 1, 2, 3, 4
IRBANA:
1. See CREDIT items:
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01/17/2009
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CREDIT:
1. When a Prestudy Patient Workup is Edited, if there are Ancillary or Other Studies of interest, they have been listed on the popup page. Now, however, if there are forms uploaded into those studies, a button appears to allow access to HIPAA, Consents, etc.. directly from the Patient Workup page.
2. If the Patient Protocol Notes are *locked* (per 1/2/09 updater) the staff name and time are now logged with the entry.
3. There is a new report: Protocol Status Change by Date. The objective is to know, within a date range, when the status of a protcol changed from one state to a new status (as selected in Multi-Select Status box).
4. Email is now a new field in PreStudy.
5. If the Patient Off Study Reason is Enabled (File Ops > System > System Variable Defaults), and an Off Study Date is entered, the Off Study Reason becomes Required.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5
IRBANA:
1. See CREDIT items:
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01/03/2009
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CREDIT:
1. When a Prestudy Patient Workup is Edited, there may be Forms available for downloading (HIPAA, Consent, etc...) if those forms have been uploaded for the Protocol under the IRB Documents page.
2. There has been a major change in the Forms Printing module for IRB Regulatory Logs. For each log entry, there is now a link to the Documents Folder where staff can create as many different Forms for any and all Regulatory Logs. When the link "Print Document" is clicked in the IRB Log entry for a protocol, the Documents Folder List pops up. Drilling down, staff can locate the exact Form they wish to Merge with the Log entry. This option is also available for Word Output.
3. New Study Review Log entries can now be Exported for Import into IRBANA.
4. If there are multiple IRBs for a given institution, any given protocol with Regulatory Log entries can now migrate those entries from one IRB to another. By default, this is disabled and will need to be Enabled via File Ops > System > System Variable Default Values > "Allow Regulatory Logs to Migrate from One IRB to Another". When Enabled, each protocol with Regulatory Logs will have a new button "Move Regulatory" at the top left of the Protocol Data Page. This button produces a popup with a dropdown of all IRBs and check boxes to indicate what is to be moved to the selected IRB per the same protocol.
5. Patient Protocol Arm Notes can now be "Locked". Each entry can be captured without ability to Edit the entry. Additional entries can be added, but no existing entry can be changed. To Enable this new feature, Main Menu > File Ops > System > System Variable Default Values > Patient\Protocol. Last entry in that section: "Lock Patient Arm Notes when Saved". By default, this feature is Disabled.
6. Until now, some reports have had a "Memory"... the report remembers who you are and how you last left the Report Selection Page. Now, multiple Memory Selections are being tested. The Report > Protocols > Principal Investigators now has a new Beta Memory Selection System. By default, the selections on the page are set to "Memory 01". The name of the Selection can be set to a New Location, say, "Dr. Bob and Open Studies". When the report is created, that new Memory Selection set is saved to the newly named location. And, existing locations can be updated. Simply make new selections, and the report will update as it normally did with the same Memory Location.
7. Protocol ORC Notes can now be "Locked". Each entry can be captured without ability to Edit the entry. Additional entries can be added, but no existing entry can be changed. To Enable this new feature, Main Menu > File Ops > System > System Variable Default Values > IRB Activities. Second entry in that section: "Lock ORC Notes when Saved". By default, this feature is Disabled.
IDEA:
1. See CREDIT items: 1, 2, 3, 5, 6, 7
IRBANA:
1. See CREDIT items: 2, 6, 7
2. New Study Log entries can now be imported. Note: The protocol file must first be imported prior to attempting to import the New Study Log for the protocol, otherwise the Log entry will not find an attaching study.
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12/13/2008
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CREDIT:
1. The Hospital Calendar now has a Reminder Feature. It is available only for single dated events. By entering the number of days in the future (30), a CREDIT mail message will appear for the staff who made the entry. Further, *if* the staff has a valid email address in their staff profile, CREDIT will email the reminder. Note: this feature is only available of InnerCircle Hosted Sites, and self-hosted sites that have ColdFusion configured to process email. There is also a new "Reminder Note" field to detail the Reminder entry.
2. The previous Updater displayed the Date and Staff associated with the Status Change of a Patient. This updater displays that information on the Patient Photo Page Toolbox when a Patient Protocol is selected.
3. The Protocol Follow-Up Sheet now displays the Arm for the Patient next to the On-Study Date. The document has also been updated with Date and Staff of Patient Status Change.
4. The Patient and Patient Archive Search Pages now display either ACTIVE PATIENTS or ARCHIVED PATIENTS.
5. The Patient On\Off Study Report now allows filtering per Gender. The report also has Summary Data when the Protocol Sorting is selected:
Gender Summary
Race Summary
Race Category Summary
6. The IRB Review Modification Form can now be launched in Word.
7. When adding a new Prestudy or Patient, the Gender "Other" has been removed. When Editing a patient, "Other" is still an option.
8. There is a new IRB Macro: @EventDate(d) where "d" is the number of days to add to the Event Date, and @EventDate(m,d) where "m" is the Months to add and "d" is the Days to add. This way, we can do something like this: @EventDate(12,-1). The result will be one year - 1 day from the event date (can be used to calculate the "Expire Date" for protocols or Consent Forms.
9. There is a new "Coordinator" available for assignment in the Pre-Study Workups. The Prestudy Patient Listing Report now allows filtering by Coordinator and it is also a new Column to Include.
10. In the Staff Profile, there is a button "Submissions". If the mouse is held over the button, a "Mouse-Over" popup appears detailing the total submissions and the number of "Outstanding" submissions.
11. There is a new feature that allows for sending Document Emails to patient. This involves the Document Processor. Create a document and then File Merge. There is a new Output Option: Email. Selecting that will automatically send the Document via email to the patients in the Merge File. Notes: 1) Patients must have an email address. Those without an address will be skipped. 2) Self-Hosting sites will need to have ColdFusion configured to be an Email Server. InnerCircle Hosted sites have this feature already enabled and are ready to email at any time.
12. The Staff\Hospital Calendar now allows for multiple staff reminders on a single event. The rules are: we determine if there are any Staff in Reminder Staff List, if so, they become the list to email to. If not, we use the Staff of the user who logged the reminder. The list of available staff for any given event is filtered for email addresses. If staff has no email address, they will not show up in the staff reminder dropdown box for selection. Also note that all staff with email addresses are available. This means staff without logon can even be notified.
13. There is a new System Variable that sets "Default Staff List" for the Reminders noted in #12 above. If there are staff listed in System > System Variable Defaults > "Hospital Calendar Staff Reminder List Defaults", those staff will automatically be selected for reminders for events entered in the Calendar. Even though they will be listed in the Calendar Event for Reminders, they will not be active unless a REMINDER DAYS value is set. Therefore, there is no need to remove them from an event that has no reminders set. They can be listed, but the event is Inactive for Reminding.
14. There are 3 new Columns in the Link Patients & Protocols Report: Primary Care Physician, Referring Physician, Other Physician.
15. The Assignment of Prestudy & Patients to Protocols is sometimes troublesome. At times the expected Protocol is not in the list. There is now a link on the word "Protocol" on the page. Clicking the link will explain several reasons why the study is not appearing in the dropdown box for selection. The message will read:
Protocols missing from this list are due to several factors:
1) Protocol is not OPEN
2) Protocol Arms are not OPEN
3) Protocol is wrong Gender for this Patient
4) Protocol Sponsor assignment is not the Selected Sponsor
5) The Protocol Department is not set, or the staff does not have access to the assigned Department.
Please check Protocol Data Page.
16. The Link Patients & Protocols Report now allows filtering per Protocol Status.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16
IRBANA:
1. See CREDIT items: 1, 6, 8, 10, 12, 13
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11/23/2008
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CREDIT:
1. Financial Invoice amounts can now be edited.
2. There are 4 new User Defined Protocol Fields available in the File Ops > System > System Variable Defaults > Protocol Data. These fields can be Titled and Enabled to show up on the Protocol Data Page.
3. Existing Financial Direct Cost entries can now be edited, provided they have not had funds allocated to the entry.
4. There is a new Financial Report: Requests For Payment.
5. There is a new Protocol Audit Log Module that replaces the old system. It is patterned after the Patient Audit Log. Auditing Agencies is managed in File Ops > IRB > Add\Edit\Delete Auditing Agencies.
6. The Pre-Study and Patient Date of Birth can now be set to a Required Field (Red). By default the field is not required. To change the setting, File Ops > System > System Variable Default Values > Patients > Pre-Study and Patient Birth Date Required: Enable.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6
IRBANA:
1. See CREDIT items: 2, 5
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10/25/2008
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CREDIT:
1. In the Prestudy Module, each Patient can now have Documents Uploaded. Then, if the patient is Activated, the list of Prestudy Documents is provided when the Arm Pop box appears. The user can select the specific Documents that will be *moved* to the Active File Cabinet with the Patient. Those documents will no longer be in the Prestudy module for the patient, but rather, in the Patient File Cabinet with the patient.
2. In the Prestudy Module, when a Patient first gets a new Workup (Screening), the Outcome can be set to a default. The default is currently "Unassigned". It can be changed in File Ops > System > PreStudy Patients > "When Patient Workup is Initiated, Set Outcome to", then select the default Outcome.
3. If Printing the CTSU-RSS Form is Enabled in the System, the Review History Page now has a link to print it directly from that page. Prior to this, the printing was done in batch mode via Reports.
4. When a Patient Status is changed, the system now captures the date and staff making the change.
5. There is a new System Variable that controls whether or not the IRB "Office of Regulatory Control" (ORC) page has the "Report Inclusion" automatically set to "Inactive" once the first IRB Review History entry is made. By default, it is set to Enabled.
When New Study Review is Created, Set Office of Regulatory Control (ORC) Reporting to Inactive.
6. If the Protocol variable "Type of Protocol" is Enabled, it can now also be set to Required. This is managed in File Ops > System > System Variable Default Values > Protocols
7. For those insitutions that have Financials Enabled, on the Invoice page, there is a new button for creating the "Invoice Header". It uses eWebEditPro to allow for image uploading and basic letterhead design. The header then displays on all Invoices when Printed.
8. There is a new System Variable (File Ops > System > System Variable Default Values > IRB Activities) that now controls whether or now an Expired Document can be Downloaded in the IRB Modules of Protocols.
9. The new Request For Payment module, Print RFP, there is a System variable that allows for displaying either: Patient Protocol ID, Patient Name, or Patient Initials (File Ops > System > System Variable Default Values > Financials).
10. There is a new column in the Protocol Status Report: NCT Number.
11. The Patient On-Study Report now allows for filtering per Race and Ethnic Category.
12. The Patient Master Schedule Report now allows for filterint per Race and Ethnic Category.
13. The Protocol IRB Follow-Up Sheets External Adverse Events can now be sorted by Event ID. The setting for this is pulled from File Ops > IRB > Edit IRB Meeting Environment Defaults > #30: Study Adverse Event Log Ordering
14. The On\Off Study Report now has the Institutions as Multi-Select rather than a single pull down box.
15. There is a new Protocol Report: "Protocols By Date". Depending on the various dates that are enabled in the System settings, this report will allow for selection of protocols within various date ranges.
16. Patient Data Management Log entries can now be Self-Replicating. When a Complete Date is entered, the event (is set up to replicate) will be recorded and create a new entry xx Days, Weeks, Months, Years from the new Complete Date.
17. Protocol Submission Log entries can now be Self-Replicating. When a Complete Date is entered, the event (is set up to replicate) will be recorded and create a new entry xx Days, Weeks, Months, Years from the new Complete Date.
18. Patient Adverse Events now have a new "Adverse Event End Date". On the Patient Adverse Event Form, there are a new set of macros to pull the date: @AEEndDate and @AEEndWordDate.
19. There is a new feature installed to help remind staff to change the Patient Status on the Protocol. Controlled in the File Op > System > System Variable Defaults > Off Treatment Patient Status Trigger: Default Status and the companion setting: Off Study Patient Status Trigger: Default Status allows the Administrator to select multiple valid status that apply to each. Then, on the patient protocol page, when the Save and Continue button is clicked, the system evaluates the Status against the settings made in File Ops. If the Patient Status selection is not one of the Target Settings, an alert popup does not allow the Save to continue until the status is properly set. By default, there are NO Status Settings, which means there will be no error checking of Off Treatment and Off Study comparing with the Status. For this to function, the selections must be made in File Ops.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19
2. There is a new report that allows for pulling the Dispense History for a Selected Patient. Optionally, the report allows for pulling the most recent Dispense for the Patient.
IRBANA:
1. See CREDIT items: 3, 6, 7, 8, 15
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09/20/2008
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CREDIT:
1. When a Prestudy Workup Protocol selection is set to UNDEFINED, when the entry is Edited, it can be changed to one of the Protocols in the Dropdown box. Prior to this, an Undefined Workup could not be changed.
2. There is a new page in the Protocol Financials: Protocol Direct Payables. Much like the Direct Costs, this module allows for the creation of entries to appear on a Request for Payment (RFP) that are not associated with patient events. Entries for individual Physicians, as an example can be loaded, then included on a RFP.
3. The Cash Receipts Journal Report now breaks down amount paid per protocol for checks that were allocated to multiple studies.
4. The Time Task Report now allows for selection (multiple) of specific tasks to report on.
IDEA:
1. See CREDIT items: 1, 2, 3, 4
IRBANA:
1. See CREDIT items:
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08/30/2008
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CREDIT:
1. When Editing an existing Patient AE, there is not the option of creating a duplicate entry for the study in the IRB. Previously, this was only available when Adding the event, not in Editing. This, of course, assumes that this feature is Enabled in your System.
2. There is a new text box on the Protocol Data Page. If this field is enabled (File Ops > System > System Variable Defaults > Protocol Data > Show Patient Calendar Notifications) the information in the new text box will display on the Patient Check-off Page (all year events). Additionally, the Title of the text box can be set in the same area in File Ops.
3. There are 2 new Macros available for the Document Processor: @CoordinatorSuffix, @NurseSuffix. These will be replaced with the content on the Staff Profile page with the Staff Name Suffix (RN, CCRA, etc...).
4. Additional Columns have been added to the On\Off Study Report:
First Name
Last Name
Street Address
City
State
Zip
Area Code
Phone number
Email
5. The Protocol Adverse Event Report now allows for filtering via Non-Affiliated, Affiliated, or Both.
6. When a new document is uploaded under a protocol, selected staff can be notified of the event. The control for who gets notified is in File Operations > System > Edit Staff Notification. If the System Server is External Email capable, emails will be sent via Internet Mail. This also requires that the staff to be notified have their email address in their profile. In the event the Server is Not Setup for Emailing, an Internal email is sent via CREDIT.
7. The IRB > Last Review Report can now be filtered by Review Type(s), Full Board, Facilitated, Exp., etc...
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7
IRBANA:
1. See CREDIT items: 5, 6, 7
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08/16/2008
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CREDIT:
1. When the status of a protocol changes from one setting to a "Target Selected" setting (Open, Closed to Accrual, Perm. Closed, etc....), selected staff can now be notified of that change via CREDIT Mail. The Targets are set up in File Ops > System > System Variable Default > Notify Staff on Protocol Status Change
Then, in File Ops > System > Notify Staff of Patient Activities, a new column can be selected to indicate which staff should get the notification.
2. The Continuing Review Report now allows the Selection of Review Types to be included.
3. Each Hospital has a button in File Operations for Logging the Expiration of Certifications. Now the actual Certification Document can be uploaded along with the Logged Entry.
4. When Editing File Operations Staff Licenses, there is now a button to "Show Attachments" which pops up all the staff attached to the selected License.
5. Staff Mailing Labels can now be filtered per Staff Capability.
6. In the File Operations Edit Staff Page, each staff can have an unlimited number of licenses. This is not new. Now, however, the actual License Document can be uploaded with the License. Once uploaded, there is a link to display the uploaded document for each license.
7. The Hospital Staff Calendar now can popup a variable number of days upon staff initial logon. The number of days is set in File Ops > System > System Variable Default Values > MAIN MENU > Show Hospital Staff Calendar. If the number of "Preview Days" is set to zero (0), the popup is disabled.
8. The Financial Invoice Module now allows for Deleting any invoice with a zero (0) dollar value.
9. Invoices now have a User Defined "Invoice Date".
10. When a Protocol Revision is entered with a CTSU Tag, there is now a link on the entry to print the CTSU RSS Form directly from the entry.
11. On the Protocol Data Page, Show Patient Attachments, the popup now is keyed to note if the "Patient Archived" vs. "Protocol Archived". Further, it the Patient is Archived, the line entry is grayed.
12. There are 4 new User Defined System Dates for Protocols. They are located, enabled and titled under File Ops > System > System Variable Default Values > Protocol Data Page. All dates are Disabled by Default and titled:
UserDefinedProtocolDate01
UserDefinedProtocolDate02
UserDefinedProtocolDate03
UserDefinedProtocolDate04
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7, 11, 12
IRBANA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7, 12
2. The New IRB Document Review module Report now allows for the filtering for NEW Documents Only, EXISTING Documents Only, or BOTH. And now the documents can be tagged to MOVE to the IRB Document Folder..
3. There is a new report limiter that allows for Staff Access ONLY to the "IRB Documents for Review". It is located in each Staff Profile.
4. There is now a link in the IRB Document Review module to navigate the user over to the Generic Forms module. It is there where Agenda and Minutes are expected to be uploaded for archival and review purposes. Note: The uploads are sorted by "Title", so there should be consistancy in the titling of documents. "2008/08/12 Agenda", "2008/08/12 Minutes", etc... Using the Year, Month, Day and title will allow staff easy access to find what they are looking for.
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07/19/2008
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CREDIT:
1. "Occupation" has been added to Columns to Include in the Link Patients & Protocols Report.
2. The Protocol Submission Forms Log Report is now interactive. Entries can now be recorded via the report.
3. The Master Schedule Report now includes the column "Sponsor" and can be sorted on that column.
4. For institutions with the Regulatory ORC Enabled, when you create your first New Study Review entry for SENT TO IRB, CREDIT automatically set the ORC Reports to "Inactive"
5. The Protocol Audit report now has an "End Date" so the complete date range of the audit for the protocol can be captured. There is also a new "Memo" field for text entry.
6. For institutions that have the Protocol Summary Enabled, the report now has a Printer Link for pop-up printing.
7. "Today" links have been added to all Prestudy Protocol Workup Date Fields.
8. If a Patient Off-Treatment or Off-Study date is entered and saved, CREDIT Ignores patient calendar events. This function has been standard since 1997. Now, however, if the entry was mistakenly made, and the user deletes the Off-Treatment or Off-Study Dates, CREDIT Un-Ignores the events in the patient calendar that were Ignored by the first action. This re-institutes the calendar for future use.
In order for this option to appear for selected staff, their profile may need to be changed to include this Access. By default, all staff with Dispense capability also have this Access.
9. There is a new Date Field available for Enabling for IRB Revisions. In File Ops > System > System Variable Default Values the last entry in the Protocol IRB Section is where the event can be Enabled. By default it is Disabled. When Enabled, the IRB Revision Log will display and capture the "Actual Event Date".
10. There is a new report: Protocol IRB Review Expire Date. This report is only available to those institutions who have the Annual Review Expire Date Enabled in File Operations. Further, the title "Expire Date" can now be changed in File Operations.
11. Each Protocol has an IRB Follow-Up Sheet for Annual Review and Audit Submission. This set of documents can now be formatted such that events that occurred PRIOR to, and INCLUDING the Last Review, can be "Grayed-Out", leaving the current events (since last review) in normal color. By default, the documents remain as they are currently, all full color. The control for this is in File Operations > System > System Variable Default Values > Protocol IRB Follow-up Sheets: Normal Display (Default) vs. Grey-Out.
IDEA:
1. See CREDIT items: 1, 2, 3, 5, 6, 7, 8, 9, 10, 11
2. When a staff with Pharm Staff Position views the Patient 1 Column Calendar, only the Drug Events display.
3. If, during the Dispense Action, an Outstanding Patient Consent is open, there is a link on the Dispense Page to allow the user to migrate over to the Patient Module to record and\or investigate the consent.
4. The Dispense Log Report now includes the Form and Quantity of the Inventory Dispensed. As an example:
C225 Cetuximab (413 mg : 5 vials of 100 mg)
5. The Pharmacy Module inside of a Protocol has a new entry in the Mini-Menu: "Documents Upload\Download". With this addition, pharmacy documents (scripts, labels, etc....) can be scanned and uploaded for audit\retrieval purposes. As an example, if a Drug Transport document is physically signed by the Receiving Pharmacy, that document can be scanned and uploaded to provide support the event physically happened. This, then, allows for the original paper document to be destroyed as the uploaded document is now electronic.
IRBANA:
1. See CREDIT items: 2, 5, 6, 9, 10, 11
2. When Importing Meeting Activities from CREDIT, if the event has a Consent Change, it is colored Red. If patients need reconsenting, the color is Blue.
3. There is a new Report for the IRB: Meeting Documents for Review. This new report allows for the selection of submission types similar to the Meeting Activity Recorder. The difference here is that all uploaded Documents are displayed with the Agenda Entry so a Reviewer can click on the link and download the file. The file automatically opens in whatever format it needs. There are a few rules that should be noted. First of all, New Studies should have all documents uploaded under the protocol in the new Mini-Menu Option: New Documents for Review. When documents are loaded there, they show up on the new Report, but with one twist. IRBANA keeps a date and time log of who and when a staff clicked on the link to download the document. This is only true of the NEW DOCUMENTS FOR REVIEW. The other upload area, which has been used under each protocol is the "IRB Documents". Those, too, are linked in the new Report as "Existing Documents". IRBANA keeps no log of who has visited those existing documents, only the new ones.
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06/21/2008
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CREDIT:
1. If Show Patient Withdrawal Reason is enabled, there can be multiple Patient Status selections to trigger the notification to staff that a Withdrawal Reason is Required. The triggers are set in File Ops > System > System Variable Default Values > #177 (approx.). When the triggers are added, and a staff selects one of the "trigger" status for a patient and hits the SAVE button, a notice will popup up if they have not also selected a Withdrawal Reason.
2. The Patient Master Schedule Report can not be filtered by Patient "Location". For this feature to display, the System setting for Patient Follow-up Locations needs to be Enabled.
3. If the system has the BSA Calculator enabled, it now includes a new calculator for BMI.
4. The Protocol Phase can now be set to a Required (Red) field. This is done in File Ops > System > System Variable Default Values. It is in the Protocol Data Page section. By default, it is Disabled.
5. When Editing an existing External Protocol Adverse Event, and there were "Parallel" entries made in other protocols, those other protocols are listed at the top of the popup page. Now there is a Checkbox next to each of the Other Protocols that, if checked, the Save will also update those entries as well. This eliminates the issue of making an entry for 6 different protocols, discovering a type or missing info, and needing to open up each "Other" study to make the correction individually.
6. The anticipated Accounts Payable Module has now been installed. We are sure there will be many changes to this new system, but we wanted to get it into your hands for testing. Every type of event can now have a "cost" or "Payable". These are collected like Patient Milestones. In File Ops you set up the list of possible institutions that you will be "Request for Payment" to.
7. There is a new Report: Protocol Deviations.
8. For CCOPs, the Credit Summary Report now allows for selecting the Type of Credit to include, RX, CC, and\or FU.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6
IRBANA:
1. See CREDIT items: 4, 5, 6
2. The new Letter Generator has an additional feature that allows for the Inclusion and\or Exclusion of Keywords. This way, if a CR has a Memo entry that contains "Closure", we can flag that entry to get a totally different Letter than the other CRs. File Ops > IRB > "Add Keywords for Letter Generator" is the pathway to add Keywords for flagging entries.
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05/31/2008
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CREDIT:
1. The Protocol "ORC Recordings" module has just been updated to include the ability to track specific events for Protocol Activation. There are 5 default events that have been pre-loaded into the module, and they are numbered to allow ordering by the user:
1. Contract
2. Budget
4. Contract Agreement
5. Invoice
3. Feasibility
Each event has a Start Date, End Date, Days of Duration, and Memo. This module has been requested by many institutions to provide a tool to chart what types of events are in progress, which events are completed, and which have not begun. In File Operations > Protocols > Add ORC Event, Edit ORC Event, Delete ORC Event, all events can be managed.
The IRB ORC Reports now allow for the inclusion of the Events, filtered by Completed or not, or both completed and not completed.
2. When editing a Protocol Arm, the Mini-Menu now allows for selection to load a different Arm into the page.
IDEA:
1. See CREDIT items: 2
IRBANA:
1. See CREDIT items:
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04/19/2008
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CREDIT:
1. There is a new Form in Reports > IRB > Protocol Termination Form. When the form is loaded, macros pull from the IRB: Review Log module for Permanently Closed Studies for a selected meeting. To facilitate the selected Status for inclusion in the Form Creation, File Ops > IRB Meeting Environmental Defaults has a new setting: "Protocol Termination Form Status Trigger" which is defaulted to "Permanently Closed".
2. The Patient Audit Report now has the Audit Date linked to pop-up the printable page for the specific linked entry.
3. Invoiced Patient Milestones are now locked and cannot be unchecked in the Patient Calendar unless removed from the invoice.
4. The Staff License Report now has links for each staff name. The link pops up the staff profile page for editing and saving.
5. There is a new CTSU "Withdrawal from Protocol Participation" form. The template is managed in Reports > IRB > CTSU Withdrawal Form. The form can be printed under each protocol in the IRB Review History or IRB Revision Log area. A new check-box allows for tagging the entry for the new form. And, once saved, a new link in the EDIT column is: "Print Withdrawal". The link pops up the document and launches the print module.
6. When editing a Protocol IRB Adverse Event entry, there is now a "Save and Print Adverse Event" button on the page. If additional studies are added via the popup edit system, the print will also load those for printing.
7. Inside of the Financial Invoices for a study, the EDIT button for Payors pops up the Mailing information for the selected Payor. A new button now allows for showing the connections between the payor and Invoices and\or Payments ("Show Attachments").
8. When a Payment is made by a Payor, and it is flagged for a different, specific, Protocol. After the entry, the Specific study can be removed from the page.
9. The mail system now allows for deleting selected messages (check boxes). Items deleted from the Inbox are sent to Trash folder. Messages deleted from the Trash Folder are permanently Removed. Messages selected for deletion from the Sent box are permanently Removed.
10. The new Protocol Importer now has System options to allow for preserving existing events even though the new protocol to import does not contain those events. This is particularly handy when staff has modified a protocol by adding Financials. Traditionally, the new protocol import would remove the Financials because the master protocol being imported did not contain those events. Now, however, those events can be preserved. The control for these features is in the File Ops > System > System Variable Default Values. Drugs, Labs, Activities, and Financials can be tagged for preserving at time of import. By default, no existing entries are preserved (which is the historical case). Administrators are urged to Enable the Preservation of Financial Events.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 9
2. There is a new Pharmacy Report: Auto Mailer. It allows for viewing all protocols and the mailing settings for each study.
IRBANA:
1. See CREDIT items: 1, 4, 5, 6
2. Meeting Minutes can now be displayed and edited under each protocol\event. Prior to this upgrade, entering Meeting Minutes for an event required using the Report: Meeting Activity Recorder.
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03/29/2008
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CREDIT:
1. The Protocol Archive system now has a new "Destroy Date" and "Destroyed" checkbox. The Protocol Archive Report allows for selection of Destroy Date as the date target.
2. The PreStudy Patient Workups have a new date field: "Recontact Date". This would be the date that the patient needs to be recontacted on... be that for an Appointment or some date in the future for re-evaluation of eligibility. The Prestudy Report also interacts with the new date field, and can be sorted and date ranged.
3. The Prestudy Patient Data Page contains the fields "Continued Contact" radio buttons. They are defaulted to "Do Not Contact". There is now a new System Variable that allows the Admin to set the default to "User Must Choose". If that option is set, and a new Prestudy Patient is added, neither the "Do Not Contact" nor the "Continue to Contact" are selected. This setup "Forces" the user to make the selection rather than have them bypass the question.
4. The Protocol Current Status Report now has a new Column: Archive Data
5. The Prestudy Patient Notepads now have the Printer Icon for popup printing.
6. The following Macros have been added to the IRB Modification Form:
@IRBCoordinatorFirst
@IRBCoordinatorMiddle
@IRBCoordinatorLast
@IRBCoordinatorTitle
@IRBCoordinatorPhone
@IRBCoordinatorFax
@IRBCoordinatorStreet
@IRBCoordinatorStreet2
@IRBCoordinatorCity
@IRBCoordinatorState
@IRBCoordinatorZip
@IRBCoordinatorEmail
@IRBPIPhone
@IRBPIFax
@IRBPIStreet
@IRBPIStreet2
@IRBPICity
@IRBPIState
@IRBPIZip
@IRBPIEmail
@ConsentChange
@ConsentChangeByWho
@ReconsentPatients
7. When a Patient Adverse Event is entered, and the "Create IRB Entry" is enabled and checked, the entry is created in the patient record as well as the IRB Adverse Event record for the study. There is now a link that allows the editing of the IRB Entry directly from the Patient Adverse Event. And, if the Adverse Event is Deleted, the matching IRB Entry is also removed. Note: Editing one of the events does *not* edit the other. They are independent entries that, if edited, both need changing.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7
IRBANA:
1. See CREDIT items: 1, 4, 6
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03/08/2008
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CREDIT:
1. The Patient Label Report now allows filtering per Patient Location.
2. If Show Departments is enabled in File Operations, the Protcool Current Status Report allows sorting by Department. Further, it now includes 2 types of graphs for Department Profiling: Bar and Pie.
3. The Hospital Specific Accruals Table that appeared from the last update in IRB Regulatory Screens has now been set as a System Variable. By default it is turned off. It can be enabled in File Ops > System > System Variable Default Values.
4. Staff License Expiration can now be requested by Specific Month and\or Year. Also, the report is now interactive. Staff Licenses can be updated directly in the report. The options are to add from -2 years to +2 years to selected licenses.
5. This for CCOPs: When creating the Text Files for submission to the NCI, CREDIT now pre-processes the datafile looking for anomolies that the NCI will reject. Cynthia Whitman (NCI) has provided DDOTS her file for submission verification. That file is now installed in your CREDIT System. Please expect that when you create your NCI-CCOP Reports that CREDIT will locate those Anomolies and present them to you on the page for fix. Typically, the CREDIT Report Name is "ECOG 0147", but the NCI wants it reported "E0147". CREDIT has dropdown boxes that let you re-assign the Report Name to match the NCI. Further, you may be required to change the Sponsor of a study in the Report, from, say CALGB to CTSU in order to locate the correct Report Name. When changing a Sponsor, the Report List is updated after you SUBMIT the corrections. Feel free to do just a few corrections, then SUBMIT. This process will continue until all events match the NCI. Then, and only then, will the Text Files For Submission be created for you. The end result should be a "perfect" data file submission to the NCI for all CREDIT Institutions!
6. The Patient Data Management Report now allows filtering by Completion Date as well as Due Date.
7. There is a new Patient Audit Environment (that replaces the older Patient Audit Page) that allows for Quality Assurance documenting as well as Document Printing. At this time, all elements of "Compliance" are default loaded into the system. In File Operations > Patients > there are 2 new data areas: Add\Edit\Delete Patient Audit Topics & Add\Edit\Delete Patient Audit Sub-Topics. The Topics are the major heading areas for the Audit Survey. Each of the Topics needs at least one Sub-Topic attached because the Sub-Topics are the elements that get evaluated in the survey. By default, several Topics have been added as well as a couple dozen Sub-Topics.
8. The Patient Audit Entry also now allows for setting a Re-Audit Flag in xx Months. The Patient Audit Report now allows for setting the Date Range into the future, and selecting the Date Target as "Re-Audit Date". The results will pull patients flagged for re-audit during the selected date range.
9. When adding Protocol Adverse Events, the Multiple Assignment Box that also allows recording for other Protocols now excludes protocols that have been Archived.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 6, 7, 8, 9
IRBANA:
1. See CREDIT items: 2, 4, 9
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02/23/2008
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CREDIT:
1. The Patient Consent Form Log has a button to popup IRB Forms loaded under the protocol (if they exist in the system). A new button "Patient Forms" has now been added to the page. The new link popsup the Patient\Protocol Forms loaded under the protocol.
2. The Event Note in the Protocol Schema Module has been expanded in size. It is now a multi-line text box.
3. The checkbox for "On study forms completed" is now on the Patient Protocol page as well as the Patient Photo page. Further, each study for the patient now has a checkbox.
4. The Patient Audit Log now has a Memo Field. That Memo also is available in the Report. Also, RN and CRA have been added as columns to include.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5
IRBANA:
1. See CREDIT items:
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01/26/2008
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Special Notice to all CCOPs: The NCI has requested that specific studies, and specific arms of those studies be reported in the CCOP Accruals tables and text files for submission into the new NCI-CCOP web site. The next submission will demand that those entries are included. However, in the past, CREDIT did not include zero (0.00) Credits; per the NCI request. Now, however, there are anomolies that the NCI *does* want reported. The solution in CREDIT is simple.
The specific Arm of the protocol needs to be opened up and the Segment Viewed where the Credit entry exists. Using the Add\Edit button, go into the Activities area and locate the Credit assignment value. Change that value to "0.001". The NCI Reports will include the patients on the Arm because there is *some* Credit value greater than zero. However, when the NCI Reports and Submission Files are created, CREDIT truncates the values to fit into the NCI format. Therefore, the "0.0001" Credit becomes "0.00". Acording to Jim at the NCI CCOP IT Department, these are the studies they want reported zero Credits: PACCT-1 Arm D, and S0500 Arm A.
CREDIT:
1. There is a new report in the Patient Column: Link Patients & Provided Drug. The report provides a listing of patients, drugs, protocols, and hospitals.
2. The Patient Audit Log Report now allows filtering per Auditing Agency. The report also has added columns with a variety of Sorts: On-Study Date, Off-Treatment Date, Off-Study Date, and Registering Physician.
3. If the System Show Departments is Enabled, the IRB Continuing Review Report now allows for selecting a specific Department (or All Departments: defaulted) for pulling protocols due for review.
4. For those systems that have the Protocol NCT Number enabled, the NCT Number is now an optional column in the Protocols Per Sponsor Report.
5. There is a new report for Physician Participation. The data is pulled from the Patient Protocol Page from all the Physicians that are listed. The "Staff Participation Report" is under the Patient column in Reports, which totals and summarizes instances of participation. The report is date ranged and based on the Patient On-Study Date.
6. A new report under the Patients Column: Clinical Trial Participation. The report simply summarizes file data for participation per Protocol Phase, Minority Accrual totals, Trials Open for Patients broken out by Cooperative Group Studies, Industry, and Other, Followup Patient Count. Active Patient Counts. The purpose of this report is simply to supply values for the "Clinical Trials Participation Award" (CTPA).
7. If the Protocol Version Date is enabled in File Ops > System, the date is available for columns to include in the Protocol Current Status Report.
8. Protocol Phase has been added as a Column to Include in the On\Off Study Report
9. The Protocol Follow-up Sheets now include the PI at the end of the Protocol Title. If Protocol Version Date and\or Protocol Closed Date are enabled in the System, those dates are also displayed above the list of Audits.
10. The Patient View Calendar now hides Ignored Events per the setting in File Ops > System > System Variable Default Values: (Hide "Ignored Events" On Patient and 1 Col. Calendars)
11. On each Patient Data Page (Photo Page), there has always been an "Alternate Contact" person's data available for entry. Now, additional Alternate Contacts can be added to the page... and the number is unlimited. There is a new link on the page: Add/Edit Additional Contacts , When clicked, a popup appears allowing for Add, Edit, Delete entries for that area. When saved, the new data is immediately loaded into the existing page without the need to Refresh.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
IRBANA:
1. See CREDIT items: 3, 4, 7, 9
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01/12/2008
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CREDIT:
1. The Institutional (Hospital) Calendars now have each past date box colored "Ivory", today's date is "Light Yellow", and future dates are "White".
2. The Report: Protocols by Made Available Date now includes the ability to select by Research Base (or all), and includes the text columns "Status Memo" and "Outstanding Issues".
3. There are 4 additional Macros available for the Modification Form:
@Status = Protocol Status
@ActiveTreatment = "Yes: xx" or "No" for counting the number of patients who do NOT have an Off Treatment date in the file.
@EventID = Revision ID
@EventDescription = Revision Memo
4. There is a new "Staff License" system in place. Staff Licenses are now unlimited. When editing a staff there will always be a blank entry to add an additional license. If that entry is created, a new blank entry will be appended for the next license.
IDEA:
1. See CREDIT items: 1, 2, 3, 4
IRBANA:
1. See CREDIT items: 1, 2, 3, 4
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12/22/2007
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CREDIT:
1. Protocol Revisions Memo can now have a default value set in File Ops > Systeme > System Variable Default Values #30.
2. The General > Staff Information Report now allows for filtering via Active, Retired, or Both. The report also allows for the selecting the column "Speciality". The report can also be sorted by speciality.
3. For those institutions that have the "Financials" module enabled, the Report "Invoice Generator" now allows the user to look at an invoice per protocol using a link to popup the proposed invoice. The dollar value is linked to facilitate this upgrade.
4. For those with Financials enabled, if there are Recurring Direct Costs set up, the Daily Notificaion System will now send email to those listed when a recurring direct cost occurs.
5. The IRB Meeting Activity Recorder now allows for the selection of "All Actions (For View Only)". Selecting this option will result in the output page not being filtered per the Action.... all actions types will appear.
6. The IRB Meeting Activity Recorder can now be ordered (sorted) by Event ID.
7. Financial Payments can now be specifically associated with a protocol.
8. Inside of a protocol, when the SHOW PATIENTS button is clicked, the display can now be sorted by Hospital.
9. The Report > General > Staff Information can now be Exported to Excel.
10. The Patient Archive Popup Box, Patient Protocol Archive Popup Box, and the Protocol Archive Popup Box now have links for "Today" and "Remove Date".
11. There is a new File Operation that allows for bulk moving patients from one protocol and\or arm to another protocol and arm. The action "Migrates" the patient. The patient is physically moved from one study to another (or one arm of a study to another). This will help move patients from an arm like "UNK" to the specific arm of randomization. Also, this will assist for patients that have been attached to the totally wrong protocol. The File Operation is the last link in the Patient column in File Operations.
12. The IRB Adverse Events Module now has a larger Text Box for adding in the Adverse Event Description. Addtionally, there is now an "Add This Adverse Event" button located directly to the right of the box.
13. The Patient Mailing Label Report now allows for the selection of specific patient status.
14. The Protocol Research Team can now be "Bulk Loaded", IF there are no existing entries in the file. This whole process begins in each Staff Profile File Op. Next to "Protocol Research Team" is now a dropdown that allows for "Pre-Assignment" of Research Contact Type. IF the dropdown has an entry selected, that team member will be loaded as part of the "Load Default Team" button found on the Protocol Research Team page. When clicked, a popup presents all of the "Pre-Assigned" staff and contact type. A check box to the right of each entry can be removed if the staff will *not* be part of the team. Checked staff will be "Bulk Loaded" when the "Add Selected Members" button is clicked from the Popup Window. Again, this option is *not* available if there are any existing team entries.
15. If a patient is also in Prestudy, but the Protocol does not have a workup, the patient protocol can now be loaded directly into the Prestudy Workups from the existing Patient Protocol Page (Event Focus). A button will appear if there is currently no entry for the Patient in the Prestudy Workups: "Add Patient to Prestudy". This button will *not* appear if the actual patient is not in Prestudy OR the patient is already in prestudy and a workup for the protocol already exists. This will facilitate staff who do not do a workup in prestudy, then "Activate" from that page. This is the reverse process which allows the Prestudy Workup to be added via the Active Patient Protocol Page.
If the Workup already exists for the Patient, the button will not be shown. Instead a "GO There" link is provided to edit the prestudy patient workup for the protocol.
16. The General Report: "Staff Information" can now be output in a 3 Column format, sorted by Staff Speciality.
17. The Research Team for each protocol (as noted in an earlier update) has been moved from the Protocol Data Page, to the Mini-Menu selection for the team. Note, however, that the Protocol Data Page header for the "Staffing Assignments" is "linked". Clicking on the link will take the user directly to the Research Team page, without the need for the Mini-Menu selection. There has also been a slight change to the Reseach Team Module. The background color of "Key Staff Contact Types" is highlighted in light yellow. There are 3 key Contact Types, and only one of each can be active in the protocol at a given time. They are: Principal Investigator, Study Coordinator, and Data Manager. The background color of those Contact Types is highlighted to allow easy selection.
18. The Logon Page now has a new link "Forgot Password?". Clicking that link prompts for a Logon Name. Once that has been submitted, the user is provided a "Security Question". If that is answered correctly, the use can create a new password.
NOTE: Until each user is asked to change the password, there will be no security questions set. Therefore, the Forgot Password link will not allow password reset. As passwords expire, each staff, in turn, will be prompted to choose from one of the pre-defined security questions and provide the answer.
19. To facilitate the exclusion of groups of Financials from being captured on a newly created invoice, there is now a set of "All" and "None" links that automatically check boxes for exclusion. This feature appears on the popup box when the "Collect Milestones" button is clicked. All potential items for invoicing are displayed. Events can be excluded by putting a check in the box under the "Remove" column. These new links facilitate that process.
20. Within each Protocol Financial Module, the Milestone Collection can now be done per Date Range. By default the Start Date is set to January 1, 1900. This facilitates getting every single event from the past. The End date defaults to "Today". There is no need in changing the dates unless it is desired to limit the invoice to specific dates (as in "last month").
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
IRBANA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7, 9, 12, 14, 15, 16, 17, 18
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11/24/2007
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CREDIT:
1. The Search Engine "Target" selection can now be reordered. At each Search Engine, the OPTIONS button starts the process.
Once the columns have been selected and saved, the subsequent page allows for changing the order of the listed targets.
This is unique per each staff. By default, the order is set as it was prior to this update.
2. There is a new Staff Access assignment that can now be controlled. "IRB: ORC Recordings". If the ORC module is enabled for Pre-IRB recording for each protocol, staff can now be provided Read, Write, or no access to the system.
3. If the Protocol Department is Enabled, a new feature allows the field to be Required. It is a check box next to the "Enable" button under the Protocols section of System Variable Default Values.
4. In the Protocol Current Status Report, the user can get the IRB of Record included in the report if the "Last Review Date" option is selected as a column to include. Now, there is a new independent column available for IRB of Record.
5. The File Op > Staff > Edit Staff > Show Existing File page now displays Staff Resign Dates. They are red in color.
6. The File Op > IRB > Add\Edit IRB Meeting Dates module has been modified. The original module pulled every date from the data table, that could be serveral years in the past to several years into the future. The problem was that it loaded very slowly (sometimes taking 3-4 minutes). Now, a new "Starting Year" option allows for setting the year (2007) such that the oldest year pulled is the selected year. While the report may still take a full minute to load, it greatly reduces load time.
7. The Hospital Calendar now has the ability to have a "Private Event" associated with each event entry. The Private event shows up on "Mouse-Over", Edit, and Itinerary Listings only. It does *not* display on the main calendar page. The "Title" of this Private Event can be changed in File Operations > System > System Variable Defaults > Hospital Calendar. By default it is set to: "Staff Coverage". If you wish to disable this new feature, simply erase the title "Staf Coverage" and leave it blank.
8. Under the Financials for each protocol, the "Accrual" page contains information about Grants and Contracts. The dates associated with those entries now have the "Today" link available. This link is only displayed if the date is currently blank.
9. The "Protocols Made Available" Report now allows for emailing the results. For this function to work, the staff to receive the email must be in the system, and their email address must be entered. Then, under File Ops > System > Edit Staff Notifications of Patient Activities , there is a new column of checkboxes "New Protocols". When a check is in that box for the staff, it is that staff who will be included in the Mail To: listing.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7, 8, 9
IRBANA:
1. See CREDIT items: 1, 2, 3, 5, 6, 7
2. @ProtocolStatus will now pull the current status of a protocol for Letter Generation.
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11/03/2007
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CREDIT:
1. The Link Patients to Events report now allows selection by Staff.
2. A new report allows for pulling protocols by Made Available Date. It is under the Protocol column in Reports.
3. The On\Off Study Report now allows for filtering per Patient Status.
4. On the Patient Protocol Page, if Data Management Forms are due, they are now listed in Due Date order.
5. The Link Patients & Protocols Report now allows filtering per Follow-up Location.
6. If the IRB Regluatory has "Document Recieved Date" enabled, the date will be displayed on the Protocol Follow-up Sheets.
7. The Protocol Follow-up Sheets now include Protocol Deviations.
8. There is a new System Variable that allows turning On\Off the display of Departments on the Protocol Data Page. By default it is Enabled. To disable this feature, File Ops > System > System Variable Defaults > (it is the last entry in the Protocol Section).
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7, 8
IRBANA:
1. See CREDIT items: 2, 5, 6, 7, 8
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10/13/2007
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CREDIT:
1. Each patient data page now has a new checkbox "Allow Postal Mailings". By default they are checked. Then, in the patient Mailing Label Report there is a box that allows only those checked patients to be included in the output.
2. The Report for Patient Data Management Submissions now allows filtering per Sponsor.
3. For those institutions that have Protocol "Central IRB Associated" checkbox enabled, there is now a place to type in the "IRB of Record".
4. The Protocol Current Status Report now allows for the Exclusion of a selected Sponsor.
5. There are new Macros available for Patient Letter Merging: @LastDoneDate, @LastDoneTime, @LastDoneNumber. These data catchers will pull the last "Completed" event from the patient calendar and replace that macro with the appropriate data. Note: For those institutions that do not have Calendar Event Number or Time enabled, only the @LastDoneDate is valid.
6. On the Protocol Data page, below the Ancillary List, there is now another list for "Other Studies Of Interest". When this list is loaded, on the IRB Documents page, the studies are now linked to the documents for those studies via a popup.
7. The Patient Photo page now has a new Note Pad: "Home Medication Notes". By default is is Disabled, and can be enabled in File Ops > System > System Variable Default Values > (arround #167).
8. There is a new field in the IRB Revision Log: "Schema Change Required". This check box also has a date field for "Verified". If an entry requires that the protocol design (schema) needs to be modified a check in the "Schema Change Require" sets the notification flag. At the top of each protocol page for that study a notice will appear:
Outstanding Schema Change Required Exists!
Calendar Verification Required.
This notice is also carried over to the Patient Calendar Page (Event Focus). The notice remains active until a date is entered under to protocol to indicate that the change to the schema is completed, and the calendars have been verified. The staff name is attached to the dated entry.
9. If the Patient Follow-up Location is enabled, that field can now be "Required" in the System setup.
10. The On\Off Study report now contains an optional Column: Patient Status
11. The Master Schedule Report can now be exported to Excel.
12. There is a new button in the upper left corner of the Patient Protocol Page (Event Focus): "New Arm". This button launches the Arm Selection Box that allows the patient to be migrated to another arm on the same study without resorting to the Photo Page.
IDEA:
1. See CREDIT items: 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
IRBANA:
1. See CREDIT items: 4
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09/22/2007
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CREDIT:
1. Attention all site Administrators: Some sites have been reporting that they are "Missing" protocols in the Open Protocol or Current Status Report. This is because every Disease Site *must* be associated with a Disease Category. Please go into File Ops > Protocols > Edit Disease Site for Protocol. Once there, Show Existing File. If not all Disease Sites listed have a Category, print the document such that you can edit each and every Disease Site and assign the Category.
2. Patient Mailing Labels can now be sorted by Patient, Zipcode, or On-Study Date. The labels can also be exported to Excel.
3. There is a new IRB Modification Form that is now available. The form will need to be created per your IRB in Generate Reports > IRB > Modification Report Form. The form populates via Revisions, Amendments, and other Reviews that have been loaded into protocol "IRB Revisions Log" for a selected meeting. A single report may be generated within each protocol Review Module. Next to the "Edit" link for each entry, there is a "Print" link that will popup the Modification Form with that entry selected and then load the printer popup.
4. The Report Staff by Component now allows filtering for Active only staff (not resigned).
5. The Patient 1 Column Calendar can now have Ignored and\or Completed Events "hidden". The features are controlled in File Ops > System > System Variable Default Values, the last entries in the Patient Protocol Section.
6. The IRB Report: "Last Review Report" now includes "Reviewed By" column.
7. If the System variable is enabled to show "Follow-up Locations" for patients, that column is now available in the report "When On\Off Study". Also added is a column for "Gender". The report can also be ordered by gender.
8. Patient Date of Birth has been added to the Patient Data Management Report.
9. There is a new Patient Report Form: New Patient Form. It is in the Patient Column, but must first be activated in the File Ops > System > System Variable Defaults > (last entry in the "Patient\Protocol Page"). The form comes with some new Macros: @Sex, @Race, @MedicalRecord, @ScheduleStart available. The form will need to be created per your IRB in Generate Reports > Patients > New Patient Form.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7, 8, 9
IRBANA:
1. See CREDIT items: 1, 3, 4, 6
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08/18/2007
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CREDIT:
1. There is a new option for printing Mailing Labels for Staff. The Criteria now allows for the selection of an Institution or Hospital. Of course, there is a need to make sure all of the staff (including Investigators) have their "Home Institution" assigned. File Ops > Staff > Edit Staff and Assignments > Show Existing File. Scan that page to see that all the staff you expect to get mailing labels for have a Home Institution. If they do *not*, you will not generate a label for that staff if you are using the Institution Specific option.
2. If a patient Off Study date was entered, all unchecked events get Ignored. Now, if that date is removed (user error), all the Ignored Events associated with the Off Study date are restored.
3. Staff Licenses have been increased from 3 to 6. And the Report > General > Staff Information now allows for including a column for the staff hospital assignment.
4. The Generic Patient Calendar now allows for the display of multiple months. Further, if the calendar display is set to only one month (default), the calendar can be exported to Excel. In multiple month display, the dates are not linked to popup.
5. On the Protocol Data Page there is a new field for the entry of the ClinicalTrials.gov Identifier (NCT Number). This field is Disabled by default. To Enable the field, File Ops > System > System Variable Defaults > Show Protocol NCT Number. It is the last entry in the section for "PROTOCOL DATA PAGE".
6. The Protocol Current Status Report (Open Protocols) now allows for Exporting the report to Excel. The box is in the lower right corner of the Selection page. If checked, the report is not generated to the screen. Instead, a box pops up prompting for Open, Save, or Cancel. The correct option is SAVE. If you open the report, it opens directly in CREDIT and you can do nothing there to manage it. Of course, you *must* have Excel installed on your system.
7. The Protocol SAE environment has up to 2 "Attribution" selection boxes. They are traditionally named "Disease" and "Drug". For the "Drug" one to appear, it needs to be Enabled in File Operations. This was an update earlier this year. Now, the System Administrator can title the Attribution "Types" as desired. For instance, one organization has them titled "PI" and "Sponsor".
8. The Patient Consent Form Log now color codes the "Ignore" column to light purple if the patient is Off Study, and dark purple if the patient is deceased.
9. The Primary, Referring, and Other Physician dropdown boxes in the Patient Data Page (Photo Page) are now limited to Doctors who are *not* Investigators.
10. For institutions that have protocol review "Expire Date" enabled, that date will now display on the protocol data page; if the display IRB Review History on Data page is enabled.
11. If there is a Memo entry in a study Review History, that memo will now be displayed on the Protocol Follow-up Sheet.
12. There is a new variable available on the Patient Protocol Page: Accrual Membership. The entry is a dropdown selection box loaded with all the sponsors. The idea here is that a patient may have a protocol opened through CTSU, but the staff needs to count accruals for other Research Base Membership requirements. To enable this feature, File Ops > System > System Variable Default Values, at the bottom of the Patient Protocol Section: Show "Membership" Association for Accruals on Patient\Protocol Page.
13. Patient Adverse Events and Safety INDs "Intensity" dropdown values can now be added and edited via File Operations > Patients > Add Adverse Event Intensity.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13
IRBANA:
1. See CREDIT items: 1, 3, 5, 6, 7, 10, 11
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07/28/2007
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CREDIT:
1. There is a new date field in Patient Adverse Events: ADEERS Notify Date. This date is optional and by default is Disabled. To enable the date field, File Ops > System > System Variable Defaults > #146 Show Patient Adverse Event ADEERS Notify Date
2. There are a series of new dates associated with Financial Contracts. They include:
3. For the Report of Protocol Status, there is a new selection box for Protocol Prefix. Most institutions have renamed this to something like "Study Data Type".
4. Mailing Labels (Prestudy, Patients, Staff) now have the Font Face as an option. The default is Times Roman, but Arial and Arial Narrow are now available for selection.
5. On the Protocol Data Page, the Check Box that was only reserved for IRBANA is now available to the other systems: "Central IRB Associated". This is a File Operation setting to Enable.
6. The Prestudy Patient Data page that now displays existing Workups, now includes the display for "Consent Date" in the workup display line.
7. There is a new Default option for Protocol SAE, Memo field. The field default information can be set in File Ops > System > System Variable Default Values > #21: Default Adverse Event Recording "Memo:" The value was requested such that new prompts, such as "Drug:" could be added to the entry.
8. The On\Off Study Report now allows for the INTENSITY to be set to "Unique" patients, meaning that the patient will only be listed once, regardless of how may protocols\arms the patient has been assigned.
9. The IRB Continuing Review Report that allows for interactive log submission now only allows the SAVE AND CONTINUE button to be clicked only once for submission, thus eliminating the possibility of duplicate log entries.
10. The Report Staff Mailing Labels now has an option to "Export to Excel", which allows that the data output will be loaded into an Excel Spread Sheet. This, of course, only if Excel is loaded on the local computer.
11. The File Op Protocols > Delete Unused Protocols, now has the option of selecting how many protocols should be checked for deletion. This because some systems were timing out trying to delete over 1000 unused studies.
IDEA:
1. See CREDIT items: 1, 3, 4, 5, 6, 7, 8, 9, 10, 11
IRBANA:
1. See CREDIT items: 3, 4, 7, 9, 10, 11
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07/14/2007
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CREDIT:
1. There is another Staff Access available for assignment: Reports: Protocol Financials. This option allows staff to have access to Protocol: Financials (already part of the Staff Access assignments), but limit staff to Financial Reporting. By default, all staff having access to Protocols: Financial also have access to this new listing.
2. The Protocols Report column can now be limited to "Current Status Report" (Open Protocols) only. The listing in the Staff Access section of each staff profile is: "Reports: Protocols (Limited to Status Report Only)". Checking this box, and unchecking "Reports: Protocols (All Reports)" will result in a single report being available to the staff. Uncheck both of the assignments and the Protocols Report Column entirely dissappears.
3. There is a new Filter in the Master Schedule Report. A number of updates ago, staff were allowed to add "Notes" to each event in the Protocol Design Module. Now, events in the report can be filtered per key word for entries that contain the specifically entered text... i.e. Filter Word "Standard" will only show events that have a protocol notation containing that word.
4. The Financial Direct Cost module now allows for entry of a "Note" associated with each cost.
5. When Collecting Patient Milestones in the Financial Module, if there are protocol event notes attached to an entry, the notes are displayed below the event description. This is also true of Protocol Direct Cost entries that contain the new Note pad from entry #4 above.
6. Manually entered events into patient calendars can now contain an attached note similar to the master protocol design event notes.
7. There is a new button in the Cascade Range of Dates for Patient Calendars. "Reset Calendar to Original State". Clicking this new button ignores all date ranges and removes all cascading from all events, restoring them to their original creation dates as dictated by the protocol design (zero days cascaded). To assist in determining if this is a desired action, the days of delay are now displayed under each dated event in the Cascade Page Listing. i.e.:
Irinotecan (350mg)
(Cascaded 7 Days)
8. There are 3 new colors available for the Institution Calendar Events: Olive, Slate, Orange
9. There is a new "Contact Type" attachment that can be assigned to each Research Team Member that is under each Protocol. There are 12 pre-loaded "Types" of contact listed by default. Also, each existing member has "Other" as the default type. PIs have the "Principal Investigator" selected as the type. The existing "Types" are as follows"
Budget
Co-Investigator
Contract
Contract Negotiator
Coordinator
CRO
Medical Monitor
Monitor
Principal Investigator
SAE
Sponsor
Other
Manager
10. There is a new variable for the Protocol Page: Study Account Number. To enable the variable, go into File Ops > System > System Variable Default Values > Protocol Data Page #45.
11. For those using the Financials module, there is a new Cost Center table that is active. The table can be loaded in File Ops > Protocols > Add Cost Center. Once the Cost Centers have been added, they can be assigned in the Protocol Financial Accrual Page. Cost Centers are recyclable. As long as one study has the Cost Center (CC) in use, with an OPEN date, the CC is not available to any other study. However, once a CLOSE date is entered, the CC can be utilized by some other study.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
IRBANA:
1. See CREDIT items: 1, 2, 4, 8, 9, 10, 11
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06/30/2007
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CREDIT:
1. The Help Button has now been redirected to the DDOTS Help Web Site.
2. The Protocol Adverse Event Report now allows ordering the table by Data Entry, or Document Received Date. If the "Document Received Date" does not show up as an option, then it is not enabled in File Operations > System > System Variable Defaults. The Document Received Date is now also a Column to Include.
3. The HIPPA Audit Report has now been expanded to include staff visits to Patient Protocol Pages.
4. When a Patient Protocol is Archived, the Mini-Menu options are now restricted to navigation between Patient Search, Patient Photo Page, Patient Protocol Page. All other menu selections are hidden.
5. When editing a Financial Invoice, Locked items now display the check numbers and payment amounts per check for each entry. Additionally, there is also a new "Balance" column indicating what is yet due on each event listed.
6. There are now options in the report for Staff Productivity. The options now allow for Filtering "Completed" events vs "Due" events. Further, there is a new Format selection that defaults to the original listing using the Columns to Include, but offering a simple summary listing with or without patients. The options for this report were requested by an Administrator who just wanted to see the numbers associated with staff contact events for the past year.
7. For those institutions that have Financials Enabled, there is a new feature in Protocol Direct Costs. A cost entry can now be tagged as "Recurring" which will allow the entry to automatically generate iterations of itself at designated date frames. To enable the recurring feaure, a Starting Date (date from which the first recurring will be calculated FROM), an Ending Date (date which will stop recurring from happening) and the Number of Months between recurring events.
Given those three pieces of information, each day when the first person loads CREDIT up, an inspection is done of all potential non-expired recurrable events. Each event is then calculated to see if this day is the day for creating a new Direct Cost iteration from the parent entry. If it is, CREDIT automatically makes the new Direct Cost entry and records what date was the "due" date. That new date is then the trigger for the next iteration (child) of the parent Direct Cost.
To terminate future iterations from an event, Recurring events can be edited directly on the Financial page. Change the Month between iterations to zero (0) or blank it out, and CREDIT will stop inspecting the event for new child entries.
This new feature allows for entering events such as "Quarterly Bill for Broadband (3 months)", "Continuing IRB Review (12 months)", etc...
8. The Patient Consent Report now allows for filtering per protocol sponsor.
9. When using the IRB Meeting Recorder for New Studies and Continuing Reviews, the Memo section of each entry is now available for editing. Also, if the System Variable is set to Show Protocol Expired Date is enabled, the Expiration date, too is available to edit.
10. When institutions are using the "Schedule Starts Date" for patient calendars, the system inspects the date against the On-Study date. If the difference is greater than 180 days newer than the On-Study date, it notes a probable error to the user, then terminates the process prompting to re-enter a more valid date. However, some organizations use Arm Z for followup. They load the original On-Study date, say 1/5/2002, then the Schedule Starts Date to begin the Calendar Creation 6/14/2007. The system does not allow this. A new variable, however, puts the control of the number of days in the hands of the Administrator.
File Ops > System > System Variable Default Values > #119 allows for the 180 value to be changed. Zero (0) disables this feature all together!
11. There is a new option in the Master Schedule Report. The option allows filtering for only events that have a comment note associated with the event. The request comes as there are often special notations in the patient record next to a specific lab that might indicate that the patient is at high risk for such an event. This options allows staff to pull all commented events coming up for the next month (or so).
12. There has been a series of updates to the Institution Calendar that is launched from the Main Menu. New are: Multiple Months can now be displayed by changing the dropdown at the top of the page from 1 up to 24 months; Jump to any Month\Year by changing the selections at the top of the page; Pop-up an Itinerary of events that can be filtered by Range of Dates (Month\Year), Excluding specifically named events (defaulting to "Color Key" for Exclusion), Include events by Color. The output page can be printed via a "Print" link on the page.
13. The Reports Module can now be limited to Protocol Current Status Report (OPEN Protocols) via Staff Authorization.
14. The patient photo page now has navigation anchors that are clickable for moving up and down the page.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
IRBANA:
1. See CREDIT items: 1, 2, 9, 12, 13
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06/02/2007
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CREDIT:
1. The Financial page for each protocol allows for the load of Hospital Address Defaults for appearing on the Invoice. Now, new fields have been added to the File Op > IRB > Edit Hospital\Institution. Those fields are for REMIT TO information. Those fields can be chosen on the Protocol Financials to be the Default Address values.
2. For systems that are using SCHEDULE STARTS for patient Calendars, The Event Focus Patient Page now checks that the date is not older than the On Study Date. The Schedule Starts date is also evaluated against the On Study Date to see of the Start Date is greater than 179 days ahead of the On Study Date. If it is, this too will throw an alert page that the action is illegal.
3. The Data Progress Popup Window that indicates that the data is being requested from the server is now active in the Patient Protocol Pages. Prior to this update, large pages taking a little longer to load, had no indicator that the system was processing the request.
4. For another level of security, there is a new table that captures failed logons (Date, Time, Logon Name, Password, User IP Address). This update sets the max login attempts to 5, with a lock on the user account for 5 minutes. This, of course, can be changed in File Operations > System > Edit Session Type for Staff Logon. Once there, the type of Session should *not* be changed, nor the Session Inactivity. However, on the "Change Session" page, the logon failures and account lockout can be changed to match local security requirements.
5. The IRB Report: First Review Report, now includes the ability to filter for the Reviewer Type.
6. The Patient Adverse Event module has been reconstructed to be compliant with all other pages under the Patient Protocol Page (Event Focus). Prior to this update, the AE module had it's own bottom Toolbox that limited navigation. Now, full navigation and calendars are available throughout the patient system.
7. There is a new report: Overdue Patient Events that allows for administrative monitoring of events that are due, but have not been checked off. This report can be run by hospital, staff, sponsor, patient, or protocol.
8. The Protocol "Current Status Report" now allows for ordering by Protocol Phase.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7, 8
2. Pharmacy Shipping Phone and Fax have been added to the Hospital module.
IRBANA:
1. See CREDIT items: 1, 4, 5, 8
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05/19/2007
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CREDIT:
1. The File Ops > Staff > Edit Staff > Show Existing File now has Alpha "Anchor" links on the page to allow navigating to selected Alphabetical Regions on the page (A-Z).
2. The "First Review Report" under the Reports > IRB column now allows for inclusion of All Status.
IDEA:
1. See CREDIT items: 1, 2
IRBANA:
1. See CREDIT items: 1, 2
2. There is a new Macro for Agenda and Minutes: @IRBExpeditedGrouped or @IRBExpeditedGrouped_number
The macros pull all expedited reviews for a meeting and cluster all of the appropriate reviews under each protocol listing. Previously (and yet now), the macro @IRBExpedited pulls the protocol repeatedly, one for each event reviewed. This process (while very functional) resulted in significant increase in the size of the Agenda. The new macro can reduce the size of the Agenda by about 25%, depending on the number of Expedited Reviews there are.
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05/01/2007
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CREDIT:
1. There are 2 new Patient Identifiers now available on the Patient Protocol Page (Event Focus). They can be titled by the user and Enabled via the System setup: Main Menu > File Ops > System > System Variable Default Values > #127 & #128.
2. Patient "Environmental Allergies" has been added to the Patient Demographics Page (Photo Page). This is the 3rd Allergy list and all 3 can be enabled via Main Menu > File Ops > System > System Variable Default Values > #149 "Show Patient Allergies".
3. When screening a prestudy patient, the Disease Site is automatically selected when a protocol is chosen.
4. When creating a Protocol Test Schedule, the Notes associated with each event are now also displayed.
5. There is a new System Variable that allows for the IRB Protocol "Outstanding Issues" to be displayed to component institutions. Main Menu > File Ops > System > System Variable Default Values > Protocol Data Page #72 :Show IRB "Outstanding Issues" to Component Institutions
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5
IRBANA:
1. See CREDIT items:
2. The Mail System has been enabled. There are currently no notification links to make it automatically function. Those features will be added in a future update.
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03/31/2007
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CREDIT:
1. CCOPs Only: The NCI\CCOP Report for Table 5 (Doctor Accrual Summary) has been updated to allow specific doctors to be excluded from the report. If the doctor does not have the CCOP Physician box checked, the doctor will be excluded from the report. And, if the doctor (even with CCOP Physician checked) has a resign date that is outside of the report range, the doctor will be excluded from the report.
2. On patient calendars, there is now an option of putting printed check boxes in front of each event (for pencil checking). Events that are already completed in CREDIT will have the box automatically display a check in the box. To enable this feature, Main Menu > File Ops > System > System Variable Default Values. The entry is the very last entry under the Patient section, around #154. Show Completed "Checkmark Boxes" on All Patient Calendars. By default this feature is disabled.
3. The Patient Calendar (standard month view) now allows for a footnote to be included. At the bottom of the calendar reads "Add Footnote". It is linked to popup a window for entering a single line notation. Once saved, the "Add Footnote" message is replaced with the new footnote information. That information, too, is linked to allow popup edit.
4. If Patient Check-off Calendars are set to allow Time of Day setting (System Variable Default Values, Show Appointment Time on Event Checkoff Page: ENABLED), the selected time can now be echoed on the other views of Patient Calendars. This new feature must be selected in the System. To enable this feature, Main Menu > File Ops > System > System Variable Default Values. Show Appointment Time on Event Checkoff Page This selection is around #135. New, to the right of Enable is a check off box for: "Echo Time on Calendars". Checking that box tells CREDIT to display the time of day on all calendar views.
5. In a recent update, patient Stratification was allowed to be Enabled. Now, under File Operations > Patients, the Stratification selection entries can be added\edited\deleted. The links are the last set in the Patient Section of File Operations.
6. When Editing an existing Protocol Serious Adverse Event (SAE), there is a new Save button in front of the Identifier. The new button is "Save as New Entry". Clicking this button creates a whole new entry in the Adverse Event Log, leaving the original entry intact. This is particularly helpful when a new SAE arrives that is almost identical to an existing entry.
7. There is now a memo box for entering information in to Protocol "Outstanding Issues".
8. The Prestudy Patient "Activate" button *is now be disabled* in File Operations > System > System Variable Default Values #81 (approx.). If you wish to re-enable the button, set the value to ENABLE and Save. This is done because the Activate button now in the Pre-study Workups supercedes the old one on the Pre-Study data page.
9. There is a new report that allows inspection of distinct events associated with each protocol arm. This allows staff to see which protocols are simply "Shells" and which ones are fully developed. Historically, some protocols may have had a simple arm created with and event "Randomization". The function of that instance was simply to allow a patient to be attached to the study without regard to a calendar of events. Today, when an active patient is accrued to that arm, no calendar is available. This requires staff to stop what they are doing, download and import the protocol from the DDOTS web site before proceeding. By running and inspecting the results of this new report, protocols can be identified as needing download and import prior to patient attachment. Reports > Protocols > Events by Protocol.
IDEA:
1. See CREDIT items: 2, 3, 4, 6, 7, 8, 9
IRBANA:
1. See CREDIT items: 6
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03/17/2007
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CREDIT:
1. The Patient Data Management Log now allows for a unique "Identifier" to be entered (helpful for Queries), as well as a "Priority Score" for the staff level of performance. The levels are: Low, Medium, Medium-High, High, Urgent. These values can also be filtered in the Patient Data Management Report.
2. Protocol "Outstanding Issues" is a new flag that can be checked to draw attention that "something" is special about the state of the study. This new checkbox is located just above the Protocol Status Notes box at the bottom of the page. If checked, a Red notice appears at the top of the page. To remove the notice, uncheck the Issues box.
3. The IRB Document Upload module now allows for "Ordering" of the listing. When a document is uploaded, there is a new "Order" number available for the user to assign. For instance, if there are 5 items listed, the new one will prompt to be item #6. By default, it will be uploaded and listed last. However, if staff wants the new upload to be tucked in between existing uploads, a simple re-assignment of the #6 to, say, #3 would upload and put that new document in the 3rd position in the list, shoving all the others down one slot. This is helpful for staff that want to have all Consent Forms clustered together, and Revisions in another cluster.
4. When a Financial Event is logged, those staff receiving an email of the event are now notified of the Name of the Financial Event as well as any Protocol Note connected to the event itself.
5. The User Logon\Logoff Report can now be filtered per hospital\institution.
6. When inside of a protocol, and the Show Patient Attachments button is hit, the resulting popup window now will note if the patient is Archived. This notation is shown in the far right column under the Institution ID.
7. The Patient Data Management Report now allows for the inclusion of the Column "Sponsor", and can be sorted (Ordered By) the Sponsor.
8. The Protocol IRB Follow-up Sheet now contains a table listing all of the Patient Status along with the number of patients assigned to the specific status.
IDEA:
1. See CREDIT items: 1, 2, 3, 5, 6, 7
IRBANA:
1. See CREDIT items: 3, 5
2. There is a new IRB Environment variable that flags event "Reviewed By" for voting inclusion in the Minutes. "Include *Vote* Totals in Minutes for the Following Review Types". All of the Review Types are listed with a checkbox next to each one. If the box is checked, the Vote Totals for those Review Types will be posted in the IRB Minutes.
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02/17/2007
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CREDIT:
1. The Master Schedule Report now allows for Primary and Secondary Ordering.
2. Protocol Financial Milestone Collection Popup now allows for header-linked ordering of the displayed data set. Each table for Invoice collection has the headers linked. Click on any header, and the data in that table will be ordered in that way. Note: Caution, checked events for REMOVAL will be lost when ordering tables via the links as the action simply reloads the entire page with the new column ordering established for the specific table. As a result, it is recommended that all tables be sorted *prior* to any items being marked for Removal from the Invoice.
3. The View Patients by Staff report now allows for multi-selections from a combination of Nurses, Data Managers, Investigators for filtering purposes.
4. The Master Schedule Report now has a Staff Memory. The selections made remain in place until changed by the specific staff.
5. The search engines now have Auto-Complete which windows down a list of searchable targets as the user types. This is a System Feature and has been Enabled by default. Should you choose to disable this feature, it is done in File Ops > System > System Variable Default Values > Search Engines. It is the last entry in the Search Engine section.
6. Protocol Arm Segments (calendar design segments of dates) can now be imported from one arm on the study to another. This may be helpful when an extensive segment is created for financials on one arm that needs to also be built on another arm. Rather than reconstruct the entire financial segment again on each and every arm, the segment can be imported from, say, Arm A to Arms B, C, etc... To reach this feature, staff must be inside of an Arm. The mini-menu "Add a Segment". There is a new button on the page with a dropdown of Segments from other Arms. Select a Segment to Import, and click on the "Import Segment" and Rename it: ____________. If there are patients attached, the user will be prompted to update their calendars. This feature could also be helpful when appending Long Term Follow-up from and Arm Z to Arms A, B, C, etc....
7. The 1 Column Patient Calendar is now capable of displaying events in different sizes, colors, and formats. The process starts in File Operations were every event (Activities, Labs, Drugs, Financials) has been defaulted to "medium size", "black", and "no formatting (bold, underline, italic)". So, if the default display for any event should be other than noted above, the event should be Edited and the display values changed. These will not change existing values in the protocol designs that use that event.... just future display values. However, when an event is added to the Protocol Design Segment, those default colors are echoed in the segment. However, they can be changed in the segment, which is the final display marker for how the event will show up in the 1 Column Patient Calendar. The table below shows the options each and every event has available.
Font Size: Small Medium Large
Font Color: Red Black Blue Magenta Dark Green Purple
Font Format: Bold Underline Italic
8. The IRB Meeting Activity Reminder Report now allows for filtering by event Status and Review By.
9. There is a new Document Submission Date available for all regulatory submissions. This date allows for the recording of when the documents were actually submitted. There is also a report available "Meeting Submission Lookup" to pull the log of Submissions within a date range. All of this is available to ENABLE via File Ops > System > System Variable Default Values > Protocol Data Page > Show Regulatory Document Submission Received Dates. By default it is DISABLED.
10. On the Patient Photo Data Page, the Patient Notes are now linked to provide a popup for printing the entire note pad.
11. The IRB Revisions and Amendments can now have a submitting\review date newer than the IRB Meeting date. There is a warning that allows the user to override the date comparisons on the fly.
12. The module that allows for "Cascade Range of Dates" for the patient calendar now has a new easy-to-use feature. Across the top of the page are 6 months of calendars that begin in the month and year of the first event that is capable to be cascaded (the "Next Unlocked Event). That date is highlighted in Yellow on that month calendar. All dated for all months are linked. If you click on a date after the "Highlighted" date, the word FORWARD will be selected in the direction of cascade box, and the number of days forward will be selected in the Days box. Likewise, if a date is clicked before the "Highlight" date, the word BACKWARD is selected in the direction of cascade, and the Days box is loaded with the number of days to move backward. This eliminates staff from counting days for calendar delays.
13. When on the Protocol Data Page and the button is hit to SHOW PATIENTS, in the patient name column is now the "Last Contact Date" and the "Next Contact Date". Note: If the Next Contact Date is less than the Last Contact Date, an event was skipped in the patient calendar and needs immediate attention. In this case, the Last Contact Date will be in Red.
14. Associated with each protocol event in the protocol design page, is not the ability to "Order" the events for creating patient calendars. So, if staff desires to have Lab A before Lab B, then Drug A then Drug B, etc..., the protocol can be assigned the order of those events. Further, in each patient calendar, Event Types can be re-ordered to allow for the groups of Labs (or other events) to have a unique display order. All this requires that a System Variable be Enabled: 'Use Protocol Assigned "Event Order" for Patient Calendars'. By default, it is disabled which causes CREDIT to function as it has in ordering events by groups of event types.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
IRBANA:
1. See CREDIT items: 5, 8, 9, 11
2. The IRB Central Committee Members now have the capacity to have a "Board Position" or "Title".
3. The Continuing Review Report now allows for the Exclusion of Existing Entries that are Expedited.
4. The results of voting entries in IRBANA are now reflected in the Minutes.
Voting:10 For:7 Against:0 Abstaining:2 Not Available:1
5. There is a new Facilitated New Study Review Letter available in the Reports.
6. The CREDIT Importer for IRB Events always captured the agency responsible for Consent Changes. Now, like CREDIT, the Importer also grabs if Patient Reconsenting is required.
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01/20/2007
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CREDIT:
1. The previous update allowed for the display of Protocol Event Comments on Patient Calendars. This replaced the "mouse-over" popup display of the notes. Some organizations, however, preferred the mouse-over to the open display of the event note. Now there is a System Default Value #144 that allows for the selection of Display vs. Mouse-Over.
2. When collecting Financial Milestones, there are new links to check boxes to Remove an entry from the collection: All and None.
3. The Master Schedule Report now allows for the Exclusion of Arms X, Y, and Z (optional).
4. There has been the ability to add Protocol Comments to each event note in the Protocol Segment Design Page (Rainbow Page). Now those notes show up as a link on the Rainbow Page for easy review. The "Mouse-over" is active as well as the new link "Notes" for each event listed. Clicking on the Notes link pops up the comment for the event. If there is no comment for an event, there is no link.
5. The Link Patients & Protocols Report and the When On\Off Study Report now allow for filtering for Archived Patients. The When On\Off Study report now also has a "Memory" to capture the last entries each user selects on the report selection page.
6. Protocol Deviations can now be exported for IRBANA.
7. Patient Adverse Event Entries can now be marked as "Follow-up Entry" Yes\No.
8. There is a new Staff Access point: Reports: Patient Adverse Event Template. "This access allows the staff make changes to the Master Patient Adverse Event Template used with Macros for importing the AE information from the patient." All staff that had access to the IRB Adverse Event area have the same rights here. If the staff does not have WRITE access to the Patient Adverse Event Template, the template and word processor are not displayed. Those staff still have authority to CREATE the Forms.
9. When a Patient Protocol is Archived, all Future Events are set to IGNORE and the Notes are populated with "Archived Patient Study". But if the Archive was done by mistake, the calendar did not "revert" to the original state of events yet to be completed. Now, un-archiving a patient protocol will remove the Ignore checks and erase the Note, properly reverting the patient calendars.
10. If the System variable: When an OFF STUDY Date is Entered, Move Financial Events to "Today" for Possible "Completion". is ENABLED, when a patient Off Study Date is entered, all non-financial events will NOT be Ignored. Financial events that are older than the Off Study Date will remain dated per the calendar. However, Financial Events that are future events have the Due Date moved to the current date.
11. There are 2 new Macros for Patient Adverse Event Reporting: @AEGrade and @AEType.
12. There is a new Macro Document on the ddotsHelp Website. http://64.109.156.30/ddotshelp/UpdatesPage01.cfm Also note that documents that are newer than 2 months, have a NEW notation next to the title.
13. New error checking now inspects dates for the Revision Log. The Submission\Revision Date must be earlier than the selected IRB Meeting Date.
14. On the Protocol Financial Payments page, there is a new column: Unallocated. This holds the remainder of the check entry that has not yet been allocated.
15. The IRB Meeting Activity Recorder now allows for the selection of Review Type (All Types, Full Board, Expedited, etc...) The default selection is made in File Ops > IRB > Edit IRB Meeting Environment Defaults #16: Meeting Activity Recorder Review Type Inclusion.
16. Drug Dosages can now be hidden on patient calendars. By default they are displayed rather than hidden. To change the setting, File Ops > System > Edit System Variable Default Values #145: Show Drug Dosage on Patient Calendars This applies only to the Patient Calendars 1 Column and 4 Column. The Patient Checkoff Calendars still show dosage and are not associated with the standard calendars. Note: The 1 and 4 column calendars may appear to be duplicating drugs with the dosage shut off. That is because some studies have a double set of the same agents, but differing dosages. Without the dosages displaying, the drugs listed will appear to be duplicate entries.
17. There are other items that can now be turned on\off on patient calendars. Auxiliary Doctor and the Protocol Title can now be disabled from display on the calendars. As with #16 above, they are System Variables #146 Show Auxiliary Doctors on Patient Calendars and #147 Show Protocol Title on Patient Calendars . By default, both are Enabled (showing on the calendars). Further, #148 Show Patient Arm Notes on Patient Calendars ,#149 Show Table Borders on Patient Calendars on the System Variables allows for Patient Arm Notes and the table borders to be turned off. By default, they are on.
18. The Master Schedule Report can now filter for Financial Milestones Completed, but not Invoiced. For this option to be seen, Financials needs to be enabled in the System.
19. Inside of each protocol there is a button to "Show Patients" when clicked, a popup box appears with all patients listed as well as some basic information about the patient (Name, Sex, Arm, Dates of Birth, On-Study, Off-Study, etc..). Now some of these listing columns are linked to the specific patient. Click on the Patient Name, and the Patient Photo Page appears. Click on the Arm, and the Patient Checkoff Calendar appears. Click on the On-Study Date, and the Patient Protocol (Event Focus) Page appears. On each of the "appearing" pages, there are buttons to "Return to Listing" or "Close Window". This facilitates staff who need to be inside of a protocol, but need access to patient information without leaving the protocol.
20. On the Protocol Financial Payment Allocation page, the Patient Milestone Column Headers are linked. Clicking on one of the headings refreshes the page, ordering the events by the column clicked.
21. Internet Explorer 7.0 had caused an issue when attempting to Add Patient to Protocol. We have coded around that IE 7 issue and those users who upgraded to that browser will no longer have a problem with that module. At this point, the systems are compatible with the new browser from Microsoft.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21
IRBANA:
1. See CREDIT items: 12, 13, 15, 21
2. Protocol Deviations can now be imported from CREDIT.
3. There are 2 new Report Letters for New Studies: New Study Pending Letter, and New Study Tabled Letter.
4. When recording Revisions via the "Meeting Activity Recorder", bullet notations can now be added to the Revision similar to those in New Studies. This is an optional feature and must be enabled prior to use. File Ops > IRB > Edit IRB Meeting Environment Defaults #50: Allow Minute and Letter Notes for Amendments. Once enabled, notes that are put in the Revision Recorder will appear on Letters and Minutes.
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01/06/2007
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CREDIT:
1. Prestudy Patient Data Records are now Archived per the Active Patient Archive Setting.
2. In the Prestudy Patient Workup page, there is now a button that opens up www.TrialCheck.org In order to use the site to search for protocol a specific patient could be considered for, you must first register. Once the registration is done, note your Logon and Password for future. For ease getting started, you can click the following link to Register: http://www.trialcheck.org/groupregistration/default.aspx?ysnShowTour=Yes
3. 2 New columns have been added to the "Current Status Report" for Protocols: "National Accrual Target" and "Subtotal Institutions Accruals". The first simply puts the Target Accruals as entered in the most recent Protocol Review or Revision. The Subtotal column reports each institution the logon staff has access to, and the total local accruals at that component.
4. The Prestudy and Patient Hospital Facility (Originating Hospital) title can now be edited. The default is "Originating Hospital" and is the #2 item in File Ops > System > System Variable Default Values.
5. There has been a report for Patient Data Management. In that report, staff can pull up submissions that are due to be completed by specified a date. Now this report allows for the direct recording of submissions. It is no longer required that staff go into each patient folder to make the recording that a specific submission has been done. It can all be done via this new feature in the Report area.
6. The Link Patients to Protocols Report now can be filtered per patient data page: "Continue to Contact Patient". There is also a column for "Contact" that can be selected for the output page.
7. The report for Patient Mailing Labels can also be filtered per #6 above.
8. The Patient Mailing Labels Report now remembers the settings for the printer (right side of the selection page). These settings are per Staff. Note: Each staff can set their own Internet Margins in the Browser Logon Page under File > Page Setup.
7. For CCOPs, there is a new report "Credit Summary". This report provides year to date Credit Summaries per Institution, Credit Type, or Sponsor. This report is *outstanding* for CCOP Credit Monitoring.
8. For those institutions that are using Financials, there is a new level for receiving payments. A new data table has been created to allow for entry of organizations or persons (other than the study sponsor) who will make payments to selected protocols. This table can be populated in File Operations > Protocol > Add Payor for Protocol. Once populated, the entries will appear on the Protocol Invoice page for selection when an Invoice or Payment is made.
This feature allows, for example, tagging a study sponsored by GSK to receive a check from PPD, or CRO. Further, checks that are entered from a selected Payor that have no association with the study are hidden from view. The new system automatically loads Payors as "Associated" when a payment is logged in a study, even if it is unallocated. That way, the new entry does not simply disappear when entered.
So, let's say that study XYZ is sponsored by GSK. GSK is the only association (by default). Now, staff logs a check from PPD. CREDIT will take the entry and make a new association for study XYZ.... PPD. The check shows up even though it has not been allocated to study XYZ because of the new association. Now, the staff can determine, perhaps, that PPD is *not* to be associated with study XYZ. Because the check is unallocated, payor PPD can be deleted from the Association list... and... the check will disappear from the display because the check was from PPD, and PPD is not associated with the study any longer.
Just so you know, if a check has been allocated to study XYZ by PPD, the PPD Association cannot be removed.
9. In mid 2006 an update allowed users to add comments in the protocol design for each event listed on the "Rainbow Page". Those events were then linked to the Patient Calendar Check-off Page. This allowed staff to "mouse-over" or click on the link to see what comment was loaded for that specific event in the protocol. Now a new feature has been added. The event comment can be displayed along with the event directly on the Patient Check-off Page, eliminating the need for staff to click on the event to display the comment. To enable this feature: File Ops > System > System Variable Default Values > #143 Show Protocol Event Notes on Patient Check-off Page. The comments will also be displayed on the Master Schedule Report.
10. Each Protocol Adverse Event that is entered now has a hidden date value that captures the date the event was loaded into the system. The benefit of this is that the Adverse Event Report for Protocols can now be selected per date range of data entry. So, staff could load AEs in for a couple of weeks, then get a report of those entries regardless of when the AE actually occurred.
11. On the Patient Photo Page the On Study Forms Completed checkbox can now be turned off if desired. File Ops > System > System Variable Default Values > #144 Show "On Study Forms Completed" Checkbox on Patient Photo Page.
12. Patients can now be assigned a Primary and Secondary Language. By default, English and Spanish have been loaded into the system. To enable this feature on the Patient Photo Demographic Page: File Operations > System > System Variable Default Values > #91 Show Patient Languages. There is also a File Operation > Patients > Add, Edit, Delete Languages system to allow additional languages to be loaded for selection.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
IRBANA:
1. See CREDIT items: 10
2. When Importing Agenda Events from CREDIT, staff can now select an alternate IRB to sent each entry. This is helpful when a variety of events come in, and some will need to be pushed to another committee. This is functional, obviously, if there are more than 1 IRB panels that meet in the same month.
Example:
You get an imported Revision file for meeting 1-11-2007, and 5 of the entries you want in the 1-25-2007 IRB-2 meeting.
This allows that you can get imports from CREDIT, and "send to the other IRB meeting" other than the import to one meeting.
So, if CREDIT sends a file for 1-11-2007 meeting, and you want that study to be in IRB-2 meeting of 1-25-2007, you can choose the IRB-2 meeting to import each selected event.
3. When multiple IRBs are involved, sometimes we need to shift Regulatory from one IRB to another. This is now easily accomplished and is available on every Protocol Data Page. If the IRP\Protocol has Regulatory Events logged, and there is another IRB available, the button will appear right at the top of the page next to the Identifier: "Move Regulatory". A popup will appear with every Regulatory Log loaded. Staff can move all events or selected events from selected logs.
Example:
Issue: I have a study that has all regulatory in my IRB-1, and I want that study to be reviewed in IRB-2. How can I move all the regulatory entries easily?
So, in this case, go into Protocols using IRB-1.
Search for, and open up, a protocol you want to "move" to IRB-2.
First thing you need to do is provide IRB-2 Access to the Protocol (bottom of the page Checkbox, then SAVE).
You will notice the MOVE REGULATORY button on the top of the page... mash it.
A popup will come up with the study ID, Title, and a dropdown box of IRBs for selection for moving TO.
In your case, there will only be one entry in the box... IRB-2.
Each table shows the items you can MOVE.
Click the ALL link under the MOVE column of check boxes for each display table.
Then, back to the top of the page to punch the "Move Checked Entries".
You will be prompted to continue.
When done, a notice will inform you of the success of the operation.
When back on the Protocol page, go to the bottom of the page again and click on the IRB-2 link next to the ACCESS box.
You will be sent into IRB-2, same protocol, without going all the way out and back in under IRB-2.
In the mini-menu, pull up the IRB: Follow-up Sheet to see what was moved.
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12/16/2006
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CREDIT:
1. Protocol Current Status Report now allows for the selection of staffing Contact Information within the RN, CRA, PI columns.
2. There is a new IRB Report to help remind staff of historical log entries that are still set to SENT TO IRB, "IRB Meeting Reminder". The report is date ranged and functions exactly like the IRB Meeting Activity Recorder.
3. The Patient Checkoff Calendar now displays the "per units" for drugs that are manually entered events.
4. When working a prestudy patient up, if the staff uses the dropdown variables at the bottom of the workup page, a note is now required if a variable is selected for use.
5. On the Patient Protocol Selection Page, when protocols are changed, as usual, the arms for the selected protocol will also change. Now, if there are any Notes for the Selected Arm, those notes will appear to the right of the Arm. When the Arm is changed, the note changes per the newly selected Arm.
6. Each Protocol can now have a "Confidentiality Agreement" checkbox associated with it. To enable the checkbox, File Ops > System > System Variable Default Values > #30 Show Protocol "Confidentiality Agreement" Checkbox will need to be set to ENABLE. By default, it is DISABLED. When enabled, the checkbox and title will appear directly under the Protocol Status Notice in the upper right of the Protocol Data Page.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6
IRBANA:
1. See CREDIT items: 1, 2, 6
2. There is a new set of Macros for the IRB Agenda: @IRBFacilitated @IRBFacilitated_number. The macro will be replaced with all reviews for the meeting that have an approval by "Facilitated".
3. There is a new option for creating Protocol IDs in IRBANA. File Ops > System > System Variable Default Values #66: Auto-Sequence Protocol IDs When Adding a New Study. When Enabled, and a starting number is placed in the Enter Next Number box, that will be the next sequencing number for the next Protocol ID when a new study is added. Then, the number will auto-sequence to the next number. Example: 200701 will change to 200702 after the first protocol is entered for the year 2007. The user will still need to place desired dashes (-) where needed for the study. NOTE: If you begin your study ID with "006...", IRBANA will drop the leading zeros. Therefore, you need to have a digit in front of the zeros "2007.....".
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11/25/2006
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CREDIT:
1. The Prestudy Patient Listing Report can now be viewed in SUMMARY Mode. See the Selection Page right side INTENSITY area.
2. The Prestudy Patient Workup now allows for Screening Location to be stored.
3. The Protocol Current Status Report now allows for inclusion of Protocol Document Links. These are documents that have been uploaded under the protocol module titled either "CCOP Protocol Documents" or "Patient Protocol Documents".
4. The Link Patients & Protocols report can now be Ordered (sorted) by Patient Status. The display output also totals each status.
5. Selected staff can now be notified when and IRB activity requires patient reconsenting. The existing system also makes a log entry into each patient consent form log associated with the study. The Notification Flag is set in Main Menu > File Operations > System > Edit Staff Notifications of Patient Activities.
6. Protocol Adverse Events has a new field available for those who have "Verbose" reporting enabled (System #18): "Attribution: Disease". The existing Attribution for SAEs continues to be enabled. The "Attribution: Disease" option is available in File Ops > System > System Variable Default Values > #21. If Enabled, the SAE recording page opens up the second Attribution assignment. When enabled, the existing Attribution is relabeled: "Attribution (Drug)", and the new display selection is labeled "Attribution (Disease)".
7. There is a new Macro for printing on the SAE Report Form: @AEDiseaseAttribution. This macro corresponds to item #6 above.
8. The Protocol Adverse Events Report now includes the Disease Attribution if the system is Enabled in File Operations.
9. The Patient Adverse Event Report Form now has several new macros: @AEIRBDate, @AESponsorNotifyDate, @AEDiseaseAttribution, @ProtocolArm. Correspondingly, there are new fields on the Patient Adverse Event Reporting Page to hold those new values.
10. When Archiving a Protocol, a patient listing will also be included for those patients that are not already archived. Staff can put a check in a box to select which patients should be Auto-Archived along with the Protocol. The information for the Protocol Archiving will be echoed in the patient archive. This process CANNOT be reversed. If the protocol is unachieved, each individual patient that resides in the Archive file will manually need to be unachieved as needed. To enable this system, File Ops > System > System Variable Default Values > #66 (Allow Automated Archiving of Patients
When Protocol is Archived).
11. The Logout Button has been moved to the upper right corner of the page.
12. The REPORTS button has replaced the DOCUMENTS button on the Navigation Bar.
13. When a local Patient Adverse Event is loaded, there is now an option to have that event copied over into the Protocol Adverse Event Log of IRB Review. To enable this option, it is suggested that #123 (Show Verbose Patient Adverse Event Columns) be enabled in System Variable Default Values. Item #128 (Show "Sent to IRB Date" on Patient Adverse Event Recording page) Must be enabled!
14. The When On\Off Study Report now allows filtering for Protocol Type. For this feature to be active, the Protocol Type field must be enabled in File Ops > System > System Variable Defaults > #48 (Show Type Of Study).
15. The Protocol Adverse Event Report now has an additional data element that can be used. When the Table Intensity is selected to be One Protocol Per Page, there is now a "Footnote" that can be appended to the bottom of each output sheet. To edit the contents of the Footnote, click on the link directly on the AE Selection page. A window will pop-up with the editor inside. Whatever is typed in and saved will appear on the bottom of each output protocol page.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
IRBANA:
1. See CREDIT items: 3, 6, 7, 8, 11, 12, 15
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10/28/2006
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CREDIT:
1. The Patient Protocol Page now has a safety feature for those who have the Withdrawal Reason enabled. File Ops > System > System Variable Default Values > #133 is where the feature is enabled. Then, #134 can be set to a specific Patient Status that will allow a Withdrawal Reason to be selected! This solves the problem of staff setting the Patient Status to "Off Treatment, in FU", then setting the Withdrawal Reason to "Lost to Follow-up". In fact, if the patient has that status, they have not Withdrawn from the study.
So, in the event the patient tries to set the REASON, without the proper status selected (normally WITHDREW CONSENT), an alert box points out the error and resets the Reason to PATIENT NOT WITHDRAWN.
2. In the Protocol Current Status Report, when IRB Document Links are requested in the output table, there is now a "Mouse-Over" that displays the Date of the Document. If there is also a date of expire, that date is shown as well.
3. The Protocol Current Status Report now allows for the selection of a column: "Next Projected Review Date".
4. The Patient Data Management Log now allows for multiple entries with one addition.
5. The Link Patients & Protocols Report has 2 new columns available: Home Address and Home Phone.
6. Patient Data Management Forms Log now has a memory. When going into the Patient Data Management Forms Log to select forms to be completed, if there are existing log entries, only those forms are listed as available for selection. There is a button supplied that allows for All Forms to be displayed. The idea here is to trim down the list of selection forms from hundreds to only those that apply to the protocol.
7. The Event Focus (Patient Protocol) page now displays Due Data Management Forms.
8. The Link Patient to Protocols report now includes the Original Consent Date as a Column Option.
9. The Pre-Study Patient List Report now allows for a simple listing (and count) of individual patients screened. This report does not allow for protocol inclusion as it would count patients multiple times if worked up more than once. The feature is located on the right side of the request page under INTENSITY: Summary Only. Please note that the CONTACT DATE on the patient demographic page is the key date for inclusion.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7, 8, 9
IRBANA:
1. See CREDIT items: 2, 3
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10/14/2006
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CREDIT:
1. There is a new format in the CURRENT STATUS REPORT for protocols. On the right side, the new format selection is: Staff and Patient Associations. When selected, the report will detail patients accrued to the selected protocols with the selected Status. Staffing assignments are summarized per Research Base and per Institution.
2. The request to allow Patient Calendar Events to have a special help notation has now been completed. Each Drug, Lab, Activity, and Financial entry in the Protocol Arm Segments now has the capability of being commented. Any comments loaded in this module will be linked on the Patient Check-off Calendar. The events that have a notation will be underlined and moving the mouse over the event will display the notation. Clicking on the link will popup an alert box with the notation inside. Note: DDOTS, Inc. will provide no notations for any protocol events. These events are meant to be locally assigned as needed by the organization.
So, why the notations. Some events (forms in particular) are only due in specific situations. Those situations can be noted now and associated with the event directly in the protocol, then show up as linked help on the patient check-off calendar. Also note that the links are ONLY available on the Patient Side of the system. They are not linked in any of the Reports at this time.
IDEA:
1. See CREDIT items: 1, 2
IRBANA:
1. See CREDIT items:
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09/23/2006
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CREDIT:
1. On the Patient Photo Page there is a new checkbox under the Alternate Contact information:
Medical and Personal Information Can be Shared with This Contact Person. By default it is unchecked.
2. There is a new location for uploading Generic Forms into the system. In Generate Reports > General a new link is Generic Forms Download. Forms that are not specific to any particular study can be uploaded and downloaded as needed. Access to this report is controlled in the Staff Profile for each logon user.
3. The Protocol Title has been added to the "IRB Follow-up Sheet".
4. There is now a place in the Staff file for loading an Identifier that may be assigned by the institution to tag staff.
5. Notifying Staff of Financial Event Completion is buried under the Protocol Financials module. There is a new File Operations > System > Staff Notifications column that will default a each protocol financial notification to selected staff. Edit Staff Notifications of Patient Activities.
6. There is a new feature available for institutions that have Financial studies. When a date is entered for a Patient Off Study, CREDIT can look into the calendar and search out Financial Events. If it locates any, it will NOT Ignore them. And, it will move the events to "Today" allowing the staff to Complete the events for Invoicing, or Ignore the events at that time. The control for this is in File Operations > System > System Variable Default Values > #110. That entry default is to Disable the feature, allowing CREDIT to function as it does now, Ignoring ALL events. This request came from an accounting office that feared they would not capture a financial event they were entitled to when the patient ends study.
7. For those institutions that have activated Appointment Times for Patient Calendars, there is a new Daily Report Option that has Hourly events displayed for each staff member. The Report is in the Master Schedule Report: FORMAT: Hourly Day Calendar. This will produce a calendar from 6:00 a.m. thru 8:00 p.m. with staff listed down and time across the top. Patient events that are scheduled for specific times are displayed directly on the time and staff coordinates.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 7
IRBANA:
1. See CREDIT items: 2, 3, 4
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08/26/2006
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CREDIT:
1. Last update for CCOPs allowed for data collection for the NCI Tables 6A, 6B, and 6C. Data for these tables is pulled from the Staff Profile page. This requires each Investigator to have data entry on the staff page. There is now a new file operation available for CCOPs that allow for bulk updating of staff for those tables: Update Investigator Practice Mode. This allows for setting the flag for "CCOP Physician" as well as the 3 year "Practice Mode" for each staff.
2. The Protocol Adverse Event Report now allows for text search entry on the Adverse Event ID. All matching entries will be displayed. The search is selective via: Starts With, Ends With, or Contains.
3. The Protocol Adverse Event Reporter now allows for Editing or Mimicking any adverse event. This is done via linking the Adverse Event ID.
4. There is a new field in the Staff Profile Page: "Pager". It is located under the email and cell phone fields.
5. The Protocol Current Status Report now allows for selecting columns: Data Manager, with a sub-column: Pager.
6. The Protocol Current Status Report now has staff "memory". This means it joins a handful of other reports that remember the selections of each staff from the last time it was used. Those selections become the staff "default" selections when the selection page initializes. Changes made to the selections become the new Defaults for the logon staff.
7. There is a new field in the Hospital Profile (File Ops > IRB > Edit Hospital...) titled: Show CTSU Form for Amendments. This selection (Active, Inactive) determines if a new checkbox will appear on the entry page for IRB Revisions under each protocol.
8. There is a new field in the Protocol IRB Revisions Log (assuming #7 above is checked) that tells CREDIT if a specific entry should be included in the Reports for Protocols: Adverse Event Reporting. This report holds the template for the CTSU Form and historically was only available for New Studies or Reviews of Studies. Now, when requesting the Create Forms option, the user is prompted to use the study Review Log or the study Revision\Amendment Log. Flagged Revisions will be included in the output.
9. There is a new System Default Values feature (File Ops > System > System Variable Default Values > #77) When Patient Workup is Activated, Set Outcome to: The new dropdown selection box allows for the selection of a specific outcome to be assigned if the patient is ACTIVATED via the Pre-Study Workup page. (i.e.: Went On Study)
10. Per #9 above, when a Prestudy Patient Workup is Activated, and the Outcome is set in the #9 above, the Prestudy Patient Workup Outcome is set to that selection. (i.e.: Went On Study)
11. There is a new link on the Patient and Prestudy pages. When a Prestudy Patient folder is opened, AND the Patient has been "Activated", the upper right corner of the page now displays: Patient has been activated Go There If clicked, immediate navigation takes the user to the Patient File Cabinet into the Active Patient Demographic (Photo) Page. Likewise, on the Patient Photo page, if the patient is also in prestudy, the link there is: (Patient Also in Pre-Study) Go There. Clicking on this link migrates the user immediately into the Prestudy Patient Demographic page.
12. There is a new data table: "Stratifications". To enable capturing data for patients from this table, the field needs to be activated: File Ops > System > System Variable Defaults > #130: Show Patient Stratification on Patient\Protocol Page. If enabled, on the Patient Protocol Page (Event Focus), the follow selections are available in the table:
"er+,er-,pr+,pr-,HERneu+,HER2neu-,Ph+,Ph-,LN+,LN-"
13. The Link Patients to Protocols Report now allows for selection of "Stratification" for filtering. Stratification is also a selectable column for the report.
14. There is a new optional format available for the Protocol Adverse Event report. On the right side of the Selection Page are now 3 options for output format: All Events in One Table vs. Separate Pages Per Protocol, vs Protocols Per Adverse Event. The first format is the traditional display. The second, however, is intended to be for a selected IRB Meeting Date and clusters all SAEs for each protocol on new pages per protocol. The header information is shown on the top of each Protocol\Page. This format was designed to facilitate creating IRB Documents. The third will list each Adverse Event and a table of Protocols that are involved with the Event. Note: Option #3 will result in as many pages as there are Adverse Events!
15. The Link Patients to Events report now allows for filtering by Sponsor Affiliation.
16. When Adding a Manual Event into the Patient Calendar, the Mimic function now has a START DATE for echoing the new event to an existing event. This allows for adding in the new event from the date forward, eliminating adding old historical events that needed to be Ignored.
17. The Add Manual Events into Patient Calendar module has been updated to allow more flexibility. In the "Multiple Dated Entries" section, users can now specify the Repeat Frequency of the event. For instance, Repeat Every 21 Days, or Repeat Every 6 Months, or Repeat Every 2 Weeks, etc... The frequency is a text box for entering numeric values.
18. The Patient Protocol Arm Notes found on the Event Focus page are now linked to popup the notepad and launch for printing. It was requested that staff be able to just print the Patient Arm Notes.
19. In the Document Processor, under the FILE MERGE module, there exists the ability to "Manually Create Patient File". The page to actually populate the file has been updated to allow for seeing all authorized patients for "All Protocols" or change the protocol dropdown for the listing of only patients associated with the protocol. This helps filter the Patient selection file for easier location of patients.
20. When entering Prestudy Patients, the Gender, Race, and Ethnic Category can now be set to a default value. These are done in File Ops > System > System Variable Default Values. In the Pre-Study section the entries will be found. Additionally, the Pre-Study Patient Social Security number can be hidden. In this same area, there is the ability to change the titling of the Workup "Consent Date". Some institutions are using the date for when they sent the consent out. So, they might change the title of the field to "Consent Sent".
IDEA:
1. See CREDIT items: 2, 3, 4, 5, 6, 12, 13, 14, 15, 16, 17, 18, 19
IRBANA:
1. See CREDIT items: 2, 3, 4, 5, 6, 14
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08/12/2006
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CREDIT:
1. The Protocol Treatment Report now allows selection per institution. The report now inspects the Protocol Title and Schema for the existence of the selected drug. Further, there are up to 5 drug selections available per search.
2. The Protocol Current Status Report now allows for inspection of Patient Calendars for any future events. This is valuable if staff are looking to see which protocols are OPEN, yet there are no future patient events scheduled for the study.
3. The new Deviation Log for IRB Regulatory has now been linked to the Patient Protocol Module. If a patient protocol ID number is loaded into the Deviation, that deviation can be seen directly in the patient protocol page via a new button "Deviations". If there are no deviations, the words "(No Deviations)" appears in the button's place.
4. The Current Status Report now has links under the Protocol Identifier. Any and all documents uploaded under the protocol "IRB: Documents" are available for opening in the report.
5. There is a new IRB Report that allows for Postponing Submissions from one meeting to another. "MEETING ACTIVITY POSTPONEMENT" it the link. This module allows for selection of the parent meeting, selection of an action (Tabled), and selection of the target meeting. Much like the Meeting Activity Recorder, this module allows for entry for the parent meeting, THEN copies the information over to the target meeting for action at that time. This module is useful in the event a quorum is not present for IRB activities, and all events need pushing to another target meeting.
6. In the File Operations > Staff, there is a new function: Update Logon-Staff Module Access
The module presents all logon staff and all Module Access for each staff. Here users can make bulk changes to staff access without needing to edit each staff profile independently.
7. CCOPs have a new set of tables for their NCI Reports: Table 6A, 6B, and 6C. There is also a verification for those tables available. This update added new fields to the Staff Profiles: CCOP Physician? (checkbox defaulted as checked, and can be changed per investigator), and 3 previous years of "Practice Mode" dropdown boxes that have selections of "Private Practice", "Salaried Academic" and "Training/Fellowship". All defaults are set to "Salaried Academic" and must be changed per investigator. These fields are required data points on the new Table 6.
8. The Patient Check-off Calendar has a new automated feature to allow Notes to be added to duplicate event types. The button is next to the NOTES header "Auto Comment". A popup allows for selection of an event to note, and a field to type the note. When saved, the note will be copied into every calendar event from the selection. Also note: if the Auto Comment field is blank, it will REMOVE any and all comments for that event.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 6
IRBANA:
1. See CREDIT items: 4, 5, 6
2. There are new Follow-up letters available for Protocol Deviations. The new macro for the letters is "@IRBDeviation". The Board Action Default insert is also new and is found in the File Ops > IRB > IRB Meeting Environment Defaults #40 and #41.
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07/22/2006
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CREDIT:
1. There is a new web "Updates" site for all DDOTS, Inc. software systems: http://64.109.156.30/ddotshelp/Index.cfm
This site has Frequently Asked Questions about CREDIT, IDEA, and IRBANA. Newly added to the site is the email listing of System Updates...(copies of these emails). That is under the page link: DDOTS, Inc. System Update History. Once inside of the Update page, users can search for specific text to find an update for review. Clicking on the Date of the Update selects that single update for review\printing.
2. For those institutions that have the System Variable Enabled to "Show Staff Notations in Patient Checkoff Calendars", there is a new Column box in the Master Schedule Report: Patient Calendar Notes. If checked, the notes show, if unchecked (default) the notes do not show.
3. When adding a study Review History entry, CREDIT takes the current status of the protocol for the institution and defaults that entry as the status as of the time of review. Now, when editing an entry, staff can change the status of an historical entry. Caution: The actual protocol status is located on the Protocol Data Page. The status in the Review History page is intended to be a "capture" of the status as of that specific IRB Meeting. The status in the Review History should ONLY be changed if it was entered in error.
4. For CCOPs, the Sex and Ethnic Participation Table 4 now paginates with subsequent pages containing the header information.
5. The Continuing Review Report now has links on the LAST REVIEW DATE to popup the complete review history for the study.
6. The Master Schedule Report now has 4 Key Word entry boxes for locating specific Patient Calendar Activities. Previously, there was only one Filter Word box.
7. There is now a "Current Consent Date" available on the Protocol Data Page. To enable this feature, File Operations > System > System Variable Default Values > # 62 must be ENABLED. By default, it is DISABLED.
8. There is now a "Termination Date" available on the Protocol Data Page. To enable this feature, File Operations > System > System Variable Default Values > # 63 must be ENABLED. By default, it is DISABLED.
9. There is a new "Secondary" Consent Date that is available for patients that are accrued to the same protocol and arm. This can happen when a study has a single arm, and the arm is simply a tissue sample. A patient may provide the sample for each surgery that would require a new consent date for each submission. If the patient is only accrued to the protocol once, the Secondary Consent Date does not display.
10. The long anticipated IRB Regulatory Deviation Log is finished. It is located in the protocol Mini-Menu with all the other Regulatory pages. The Deviation can simply be added or the Add & Print button allows for immediate printed output. Prior to use:
You will need to go into File Ops > IRB > Add Regulatory Deviation Type
Sample:
Emergency:
Eligibility
Study Drug Dosing
Use of Device
Preparative Regiment
NonEmergency:
Laboratory Requirements
Procedure Requirements
Follow-up Requirements
Other (Explain Below)
Then, go in and add Questions: File Ops > IRB > Add Regulatory Deviation Question
Sample:
Did the deviation affect the rights, safety, or welfare of the subject? (if YES, explain)
Was the deviation instituted to protect the subject from immediate hazard?
Did the deviation affect the integrity of the study data?
Has this deviation occurred in the past? (if YES, explain)
Has this event been reported to the Sponsor? (if NO, explain)
11. There is a new Report Form in the IRB column: Deviation Report Form. A sample form has been added to each IRB. This form can be edited in the stated report. The macros available for the report are in the form.
IDEA:
See CREDIT items: 1, 2, 3, 5, 7, 8, 9, 10, 11
IRBANA:
1. See CREDIT items: 1, 5, 7, 8, 10, 11
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07/03/2006
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CREDIT:
1. The Patient Protocol Original Consent Date display can now be controlled via File Ops > System > System Variable Default Values #127:
Show Patient "Original Consent Date" on Patient\Protocol Page now has 2 options:
Enable, Allow Staff Entry
Disable, Use On-Study Date to Populate
By default, it is set to ENABLE. If you wish to hide the Original Consent Date and have it prepopulate when adding a patient to a protocol (using the On-Study Date), DISABLE this feature.
2. When Patient Death Date is Entered, Set Patient Status to: is now available in System Variable Default Values #82. The Status selections are specific for each installation. This value *needs* to be set. Do not delay! The default is currently set to "Off Study".
3. The Protocol Current Status Report has had an additional column added: Last Review Date.
4. The Master Schedule Report now allows for selection of a column for: Follow-up Location for patient visits as defined on the Patient Protocol (Event Focus) page. In order for this column to be available, the File Operations System variable #89 must be enabled: Show Patient/Study "Follow-up Location"
5. The Current Status Report for Protocols now has 3 new columns to include: Alternate Protocol ID, Alternate Hospital Protocol ID, Accrual Patients being Followed.
IDEA:
See CREDIT items: 1, 2, 3, 4, 5
1. The Protocol DAR now has the "Navigation Man" available for saving the location as a "Favorite". The option is now also available on the Dispense Page.
2. On the Dispense Page, the Patient Name is linked such that clicking on it will bring up the Patient Demographic Page. The same is true of the Patient DAR Page.
3. For agents that are Transported, the WHERE information is now displayed under "Transport to".
IRBANA: None
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06/17/2006
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CREDIT:
1. The Report On\Off Study now has summary capability. By selecting the Ordering by PROTOCOL, sub categories can be summarized. Note: For the report to summarize, the INTENSITY must be set to:Patient Count Only
2. The Patient Archive Location Report has been modified to include Location Selection per Patient Archive or Patient Protocol Archive.
3. There is a new section on the Patient Photo Page: Patient Allergies. 3 Radio buttons are selectable:
Not Assessed
No Known Allergies
Allergies
Also, under these selections are 2 text boxes for loading Drug Allergies and Food Allergies.
IDEA:
See CREDIT items: 1, 2, 3
1. In the View Drug Inventory page, now displays the Protocol Arm as well as the patient if the drug is patient specific. Further, if the Agent is EDITed, the patient assignment can be changed! Of course, the change causes an entry in the DAR to reflect patient re-assignment. This can be helpful if a drug is specific to a patient on Arm A, then the patient migrates to Arm E where the same drug is provided. Historically, IDEA had the drug locked down to Arm A and it would not show up on the patient Arm E. Now, the drug can be re-assigned to Arm E for the patient.
CAUTION: This change to IDEA has huge ramifications. Because you can re-assign a drug to anyone on the study, it is possible to re-assign a patient specific drug/placebo to another patient for dispensing! The user takes full responsibility for this action which could produce a violation of drug dispensing.
2. In the Staff Access section of the Staff Profile, there is an entry:
Pharmacy: CREDIT Patient Checkoff Agents
If the WRITE box (Right) is checked the staff can place patient event checks in the Completed column of an event controlled by IDEA. If the check is in the READ box (Left) the staff can only check the IGNORE column of an event controlled by IDEA. If neither are checked, the staff cannot put checks in COMPLETED nor the IGNORE column of events that are controlled by IDEA.
3. When dispensing to a patient for the very first time, the message about Excessive Agent has been suppressed.
IRBANA: None
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05/27/2006
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CREDIT:
1. For those installations that are CCOPs, the Protocol Report Name is limited to 17 characters for National Cancer Institute File submissions. So, if a protocol Sponsor is affiliated with the NCI, the user is alerted that this is a data violation and the Report Name is over sized. For those protocols that are NOT affiliated with the NCI, there is no limit to size.
2. There is a new title variable in File Operations > System > System Variable Defaults > #74: Primary Care Physician Title. By default it is set to: "Primary Physician". Both the title and description can be changed.
Note: the document macros for this field have not changed: @PDRFirst (Primary Dr. First Name) and all other macrors related to the Primary Physician remain the same and are pulled from this data entry.
3. The Patient Adverse Event entry can now be printed directly on data entry. Instead of using the "Save Adverse Event" button, there is a new button next to the existing one: "Save and Print this Adverse Event". The form used is the same one that the Patient Adverse Event Report.
4. IRB Revisions can now be inserted for multiple protocols. The multiple protocol selection box at the bottom of the page allows for adding and removing additional entries via protocol selection.
5. There are 2 new field columns available for editing in the Protocol Submission Log:
Requested (date)
Completed (date)
These can be changed in File Operations > System > System Variable Default Values
#22: Submission Log Date "Submission" Title
#23: Submission Log Date "Completed" Title
6. The Protocol Submission Log now does not require the DUE DATE.
7. The Report for Protocol Submissions now allows the selection of date titles as the target of the Date Range entries.
8. The Hospital Staff Calendar now captures the date and time the entry was created. When the event is "mouse overed", the authoring Staff Name as well as the entry date and time are shown. Historical events are defaulted to the first date the event is on the calendar.
9. The Pre-Study workups now allow for the selection of an Investigator.
10. The Pre-Study Listing Report now allows for pulling the data per Investigator. 2 New columns have been added for selection: Investigator and Data Manager.
11. If "Financials" are enabled for the installation, the study Sponsor mailing address information is now availabel in the File Operations > Protocol > Edit Sponsor for Protocol. By populating the information on this page, the Default Payor information can be copied in the Financial Pages for any given study.
12. CTSU RSS Form Creation: CREDIT can now complete the CTSU IRB Certification forms. The settings for this to occur are numerous, but well worth the time. In the Reports > IRB there is a new link to the form itself: CTSU RSS Form.
There are several new Document Macros used in the form template:
Macros Used in CTSU RSS Form
Description of Macro
@National
Protocol Identifier
@VersionDate
Current Protocol Version Date from Data Page (new)
@ProTitle
Protocol Title from the Data Page
@IRBPISal
PI Salutation from Staff Page
@IRBPIFirst
PI First Name from Staff Page
@IRBPIMiddle
PI Middle Name from Staff Page
@IRBPILast
PI Last Name from Staff Page
@IRBPINumber
PI NCI Number from Staff Page
@NSX
If the study is a “New Study”, replaces with an “X”
@AmendX
If the review was an Amendment, replaces with an “X”
@ERC
Replaced by 8a, 8b, or 8c from the CTSU Form
@RenX
If the review was “Continuing”, replaces with an “X”
@FBX
If the action was by Full Board, replaces with an “X”
@ExpX
If the action was Expedited, replaces with an “X”
@FacX
If the action was Facilitated, replaces with an “X”
@IRBMeetingDate
Meeting Date (mm / dd / yyyy)
@IRBNumber
IRB Identification Number (new)
@IRBExpireDate
Action Expiration Date (mm / dd / yyyy)
@IRBComments
The Memo field from the protocol Review page
End of CTSU RSS Form Macros
There are 2 new Macros created for this form: @VersionDate and @IRBNumber. The Current Version Date is now located on the Protocol Data page. The IRB Number is found under File Operations > IRB > Edit IRB Meeting Environment Defaults. The IRB Identifying Number is the First Field on the page.
Once the CTSU Form Template (with Macros) has been loaded into CREDIT, it can be run against a selected IRB Meeting Date. All of the Reviews for that meeting will be pulled and multiple documents will be created on the screen for immediate printing.
Save both of the attachments for activating the CTSU RSS Form in your system. The CTSUForm.txt file is a web html language version of the form. The word document is the instruction set for processing the text file.
13. There is a new "Current Protocol Version Date" that can be enabled in File Operations > System > System Variable Default Values > #30 Show Current Protocol Version Date. If enabled, the new field will display on the Protocol Data Page. This field is used in the CTSU form noted above.
14. If the institution has Financials enabled for studies, there is a new checkbox on the very top of each Protocol Data Page: Disable Financial Tracking: This box is checked to inform the system that no Financial Milestones will be collected for the study. By default, either this box needs to be checked OR at least one check needs to be placed in the Financial Milestone Collection box at the bottom right of the data page.
15. Both the IRB Adverse Event and IRB Revision Logs now allow for entering a unique Event Date if multiple IRBs are selected for inclusion in the Log entry. Please note: The multiple IRBs will NOT be populated unless the boxes are checked under the abbreviation for each IRB. For single IRB entry, ignore the default dates set in the Event Date settings. DO NOT Remove the dates as CREDIT inspects for valid dates just IN CASE you wanted multiple IRB entires.
16. The Patient Master Schedule Report now allows for "Filtering" of Activity Events per a new "Filter Word". This way, staff can pull all events that have the word "Form" or "RN" or any other series of search letters. This will not guarentee that ONLY Forms will come up, of course, as there are other activities with the letters "form" imbedded. And, if you specify "Forms" you will not get "Follow-up Form" as there is no "s" in "Form". If this is an area that you are considering filtering with, consider editing your Activities so that they have common character targets. You might change all of your different types of forms to begin with "Form:". Then you can pull all of the "Form:" matches.
17. The Pre-Study Patient Listing Report now allows for filtering by Consent Date.
IDEA:
See CREDIT items: 2, 3, 4, 5, 6, 7, 8
IRBANA:
See CREDIT items: 4, 5, 6, 7, 8, 12, 13, 14, 15
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05/13/2006
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CREDIT:
1. When Cascading Patient Calendars, if there are Staff Notations within the calendars, those entries are moved in concert with the actual check-off events.
2. The Report: On/Off Study\Birth\Death now includes the ability to filter by Off Treatment Date.
3. The Patient Mailing Label generator now allows for selection by Staff. It also includes the ability to select patients per Month of their Birthdate.
4. Under each Protocol Arm, there is a new Mini-Menu option: "Change Arm Identifier". This option allows for the re-assignment of an Arm to another identifier (A to E or UNK to A, as an example).
5. The Adverse Event entry page has been updated to include:
Expected
Unexpected
Unassigned
These are "Radio Buttons", and the default selection is "Expected". To enable this feature, the File Operations > System > System Variable Default Values #19 needs to be Enabled: Show Protocol Adverse Event "Expected\Unexpected" Option.
6. The Protocol IRB Adverse Event page now has a field for entering the Patient ID Number is provided by the study sponsor. The page also allows for adding in the MedWatch number. For this feature to be seen, it needs to be Enabled in File Operations > System > System Variable Default Values > #20: Show Protocol Adverse Event "MedWatch" Number.
7. The Protocol IRB Adverse Event page now has the ability to "Print" the institution's Adverse Event Report. Typically the printing is done under Generate Reports > IRB Adverse Event Reporting. This utilizes the eWebEditPro document processor to create the actual AE Report. The document then has imbedded Macros (data placeholders) so the template is universal to any and all Adverse Events.
Now, that same printing output is available directly on the protocol AE page. The "Print" link is located beneath each "Edit" for each entry. Click the link to Print and a popup appears with the AE data inserted into the document, ready for printing.
8. When adding a new Adverse Event into a Protocol, there is a new ADD button at the bottom of the page: "Add and Print this Adverse Event". Clicking this option not only adds the event in, it pops up the Report for the AE ready to print. This option is ONLY available for systems that have the Verbose Reporting enabled in File Operations > System > System Variable Default Values" > #18:Use Extensive Protocol Adverse Event Recording.
The automatic printing feature even captures multiple AE entries when an event is also loaded into other protocols at the same time. So, creating the event, and assigning it to 5 other studies creates the Printing Pop-up with all 5 AE Reports loaded!
Here is the list of available Macros for the AE Report template:
Protocol Adverse Event Macros
@National
National identifier for the Protocol (S0000)
@Local
Local identifier for the Protocol (HSR-20-1234)
@InitialApproval
The oldest dated entry for Protocol Reviews for the study
@IRBPIFIRST01
IRB Principal Investigator's first name for this protocol
@IRBPILAST01
IRB Principal Investigator's last name for this protocol
@IRBPIPhone01
IRB Principal Investigator's work phone number
@AlternateLocalID
The alternate local ID for the study. This field can (and normally is) renamed by the institution. However, whatever it is titled, the macro remains the same.
@ProtoTitle
The title of the protocol as entered on the protocol data page.
@AEIdentification
The Adverse Event Identifier as entered for the event
@AEMemo
The Memo portion of the Adverse Event as entered
@AEWordDate
The Date of the Adverse Event in word format
@AEAffiliated
Return either “Affiliated” or “Non-Affiliated”
@AEPatientID
The ID number of the patient if loaded in the Adverse Event
@AEMedWatch
The MedWatch Number if loaded in the Adverse Event
@AEIntensity
Returns the Intensity of the event as selected in the event entry (institutions vary on these selections):
Not Serious
Serious/Non-Life Threatening
Life Threatening
Fatal
@AEExpected
Returns either: Expected or Unexpected
@AEAttribution
Returns the Attribution list as selected in the event entry:
Not Related
Unlikely
Possibly
Probably
Definitely
Cannot Determine
@AEConsent
Returns either: Yes or No for whether there was a consent form change due to the Adverse Event Entry
@AEPatientConsent
Returns either: Yes or No for whether there was a consent form change that requires patient notification due to the Adverse Event Entry
@AEStatus
The current status of the protocol at the time of document merging: OPEN, CLOSED TO ACCRUAL, etc…
@AEActiveTreatment
Returns either: Yes or No depending if patients in the institution (or affiliates) are still taking study drugs.
@HOSP
Returns the acronym for the institution (SJMH, LSUMC, etc…)
End of Adverse Event Macros
9. On the Patient Protocol Page, the titles for "Off Treatment" and "Off Study" have been changed to become System variables, which means the title for the date boxes can be changed. File Operations > System > System Variable Default Values > #43: Off Treatment Date Title #44 is the description, #45 Off Study Date Title with #46 being the variable title description. By default, the titles are set to: "Off Treatment" and "Off Study" respectively.
10. Staff Mailing labels can now be filtered per:
Investigators
Coordinators
Data Managers
Primary Care Doctors
11. There is a new setting available on the Patient Protocol page: Require Withdrawal Reason.
It is controlled via: File Operations > System > System Variable Default Values > #119 Withdrawal Patient Status Trigger: Default Status. This is where the selection of Patient Status is set to the trigger (i.e.: Withdrew).
Also note that #118: Show Patient Withdrawal Reason needs to be enabled.
Once the settings are set, and a staff selects the Withdrawal status for a patient, they will be prompted to select a Withdrawal Reason upon saving.
12. The On Study Report can now be selected to:
Patient Count with Listing
Patient Count Only
This is available for accrual counting per physician, gender per protocol, and race per protocol.
IDEA:
See CREDIT items: 1,2,3,4,5,6,7,8,9,10,11,12
IRBANA:
See CREDIT items: 5,6,7,8
The IRB Meeting Agenda now has a new set of macros:
C. Administrative Review
@IRBAdministrative
@IRBAdministrative_number
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04/22/2006
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CREDIT:
1. The File Ops > Staff > Edit Staff and Assignments > SHOW EXISTING FILE now allows sorting by column head directly on the display page. The sortings are: Name, Institution, and Position. Clicking on one of the links redisplays the page in that selected order.
2. On the Patient Calendar Cascade Page, there is now a link to "Next Unlocked Event" to anchor the user to the next open event for Cascading. At that point in the Calendar, there is a "Top" link for quick jump to the top of the page.
3. There is a new Financial Report: Protocol Milestone Payments. Select the protocol and the report will splay payments (by check) across a colored grid indicating which checks paid which Milestones. Multiple payments to the same milestone are also supported. Milestones that are "Ignored" are removed from the grid and not counted in the total values per milestone.
4. There is a new File Operations System Variable Default #115. Hide Patient Checkoff Ignored Events that is set to DISABLE by default. If enabled, when the Patient Checkoff All Events button is clicked, any Ignored events will not be displayed. This speeds up (significantly) a long calendar where there are a lot of ignored events. To facilitate, there is a new button that will display at the top of the calendar to Show "Ignored" Events. When the events are shown, a new button is available to Hide "Ignored" Events.
If there are no events Ignored on the patient calendar, no buttons appear.
5. On the Patient Protocol Page (Event Focus), below the BSA calculator there is a new button for Archiving the Patient Protocol. Similar to Archiving the Patient, this module allows for just archiving the study. Using this module will Ignore all future events for the patient on the study.
On the Patient Data Page, where the Protocols are displayed (on the Toolbox), Archived Studies appear in Red.
6. The Link Patients & Protocols Page now allows for the selection of Intergroup Number as the target Protocol. The output can also be sorted by Intergroup, and doing so limits the output to ONLY those studies that have an Intergroup Number entered on the Protocol Page. In the Columns to Include area, there is also a new checkbox for the column Intergroup.
7. There are 3 new Document Macros available for letter merging:
@NextDrugDate
@NextDrugTime
@NextDrugNumber
These data place-holders pull the next open DRUG events from the patient calendar, and put in the appropriate information. Of course, the Time and Number need to be ENABLED in the File Operations > System environment for those pieced of data to be available in patient calendars.
8. The Protocol Current Status Report has been providing the number of Accruals as an optional column. Now, that column can be expanded to list the specific patients associated with the Accrual Number. Further, if the System Defaults has the Protocol Closed Date field active, that column is now available in the report as well. Additionally, a separate column for the protocol Status is available (by default it is listed directly under the Protocol ID in the output table).
Further, the report now includes the optional "Alternate Protocol ID" that some institutions have Enabled in File Operations (#30-#31).
9. The When On/Off Study report now allows for the EXCLUSION of the "Survival" Protocol as well as studies with patients associated with Arms X, Y, and Z.
10. On the Patient Protocol Page (Event Focus), if the patient has been unblinded, the notice and drug are shown in the upper right corner of the page.
IDEA:
See CREDIT items: 1, 2, 4, 5, 6, 7, 8, 9, 10
IRBANA:
See CREDIT items: 1<>/b?
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03/25/2006
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CREDIT:
1. The last update changed the Protocol Review Duration from Days to Months. However, sometimes simple months do not work. As an example, we want to review a protocol every 11 months. The last review was 3/5/2005. Our 2006 meeting in February is 2/9/2006. 11 Months from the 3/5/2005 meeting is 2/5/2006. CREDIT sees the February meeting date less than 11 months from 3/5/2006. So, CREDIT assigns the study to the January meeting date of 1/12/2006. This "seems" like a 10 month review, but CREDIT "calculates" it to 11 months.
2. In order to help CREDIT calculate a more reasonable review date (2/9/2006), there is a new variable in the IRB Environment (File Operations) titled "IRB Review Hedge Days". By default it is set to 7 days. This helps push the Review calculation into the more logical month. This value may need to be changed based on how many IRB meetings are held per month. This value can, logically, be put to 15 days if there is only one meeting per month.
3. For those organizations that are CCOPs, there is a new report in the Protocol column:
Protocol Credit Values
The simple report presents every protocol in the system, the Sponsor, Credit Value, and Credit Type.
4. The Financials Module now allows for the editing the amount of an entered check.
5. Patient\Protocol Unblinding is now a new Report under the Patient Column. There are 3 steps that result in the creation of patient specific letters of notification, and they begin in Reports > Patients:
a) Unblind Protocol Patients then select the Protocol (P-2). Choose both drugs in the selection box. Fill in the information on the left side of the Report, then CREATE REPORT. All patients on P-2 will come up with a checkbox for indicating which drug the patient received. When all patient checkboxes are completed, click on SAVE CHANGES. (This report can be run many times. It just records those patients that you checked. The others can be done at another session.)
b) Unblinded Patients Select all appropriate information (Protocol, Patient Status, Unblinded Date). Then, in the lower left of the page, check EXPORT TO MERGE FILE, and give the file an appropriate name (Ralox-On Study, or Ralox-Off Study) depending on your selections on that page. CREATE REPORT. All patients will come up for your selection. More importantly, the Merge File for the Document Processor will have been created.
You will need to run this report for each Distinct Letter you plan on sending out; one for Ralox-On Study, one for Ralox-Off Study, one for Tam-On Study, one for Tam-Off Study. However you break out your files per above, that is how many distinctly different letters you will plan. In this case, I am planning 4.
c) Open the Document Processor and create your files using macros: (See photo below if your email allows, otherwise, view the attachment.)
Notice the @Signature macro. If you have a scanner, sign your name to a sheet of paper (use a heavy felt tip as the web will thin it down to about 1/4th the thickness). The saved file should be about 1" in height, and a resolution of 72. If a higher resolution is set, the signature will grow in size on the final letters. Use File Operations > Documents > Staff Signatures for Merging for uploading the signature file. Locate the File to Upload, and give it a name with no spaces nor punctuation (DrRobertESmith). Do not include the word "Signature" in the file name when uploading.
Click on the "File Merge" button and locate the file you created in step b). Important: If you have your signature set, you must use the Output to screen (for quick printing) option. The signature will not show up if you send the letters to Word. Click the button "Create the Merged Document". It takes about 3-5 minutes for CREDIT to create 200 letters. They will display on the page and appear as on long letter. There are hidden page breaks that will page correctly when printed.
A final note on Merge Macros: If you are using letterhead and need to have the text move down a set number of lines, use the macro @Lines(xx) where "xx" is the number of lines you want to shift the letter down the page. You can test the spacing by doing a SINGLE MERGE and selecting a single patient for the test.
6. The Current Status Report now allows for a column to include Patients Enrolled.
7. There is a new Logon Pop-up Blocker Detector. In the event a logon fails due to a popup blocker, the user will be notified that they must edit the blocker to trust the site.
8. The "Internal Accrual Credits" Report now allows for the "Base Report" to be pulled from the Component Institutions vs. the Research Bases (which is still the default selection). Historically the report only allowed data to be sorted by the Research Bases. Now, by selecting the optional "Hospital" as the base, the reports are presented by component rather than by the Research Bases.
9. The financials module has now been broken out into 4 distinct modules. When you now launch, you are sent to the Invoice\Payments module. Once inside, you will see that the Mini-Menu now contains a link to all of the other modules. This will facilitate faster loading of the financials system.
IDEA:
See CREDIT items: 1, 2, 5, 6
IRBANA:
See CREDIT items: 1, 6, 8
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02/25/2006
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CREDIT:
1. There are several corrected titles in Reports.
2. The Protocol Review Duration has been reconfigured from Days to Months. Previously, 334 days "meant" 11 months. Now, users will simply see Months on the Protocol Page.
3. Protocol Type has been added to the Current Status Report for Filtering Purposes.
4. Email has been added to the Patient Data page.
5. The Report "Staff Mailing Labels" now has filtration for Active vs. Retired Staff
6. The Report "Staff Mailing Labels" now has filtration for Staff Specialty
7. The Report "Staff Mailing Labels" now allows for creating a Merge File of Staff for Mailings via the Document Processor
8. New macros have been added to the Document Processor to allow for Staff Letters to be created:
@SSal
@SFirst
@SMiddle
@SLast
@SStreet
@SCity
@SState
@SZip
@SPhone
Depending on the Merge File, the Home or Work address information is used.
For #7 to work, you will need to select the SPECIALTY in each Staff File. If you need to add Specialties to the dropdown list, that is in:
File Operations > Staff > Add Specialties for Staff
Populate that file with all your entries (Surgeon, Oncologist, Radiation, etc...). Then open up each Staff File and select the appropriate Specialty for each staff. That selection is what #5 (above) pulls from to create the Merge File.
Of note: CREDIT will use Either the Home Address or Work Address (you select when getting the report). If you select Work Address, only the First Work Address for the staff us used (there are 3 possible addresses for each staff... they are controlled in your File Ops > System > System Variable Default Values).
IDEA:
See CREDIT items: 1, 2, 3, 4, 5, 6, 7, 8
IRBANA:
See CREDIT items: 1, 2, 3, 5, 6, 7, 8
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01/28/2006
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CREDIT:
1. The original Patient Consent Date is now displayed (and can be changed) directly on the Event Focus (Patient Protocol) page.
2. When inside of the Master Schedule Report, when a patient name is clicked, the popup now includes a listing of all protocols the patient is registered on. The popup also includes the patient demographics.
3. Patient Mailing Labels now allow for Upper and Lower Case formatting.
4. The Report: Master Patient Calendar now allows for a Julian Calendar format (by selecting: Single Patient\Date Calendar). BE CAREFUL HERE! This is intended for use in Follow-up when staff wants a calendar for all patients on P-2 who are coming in for the next 6 months. IF you use this format for general event notices, the calendar will be huge and will require many pages to print one month.
5. In the File Operations > System > System Variable Defaults Values > #113 the Variable Patient Withdrawal Reason can be Enabled, Disabled. By default, it is Enabled.
6. For organizations that are National Cancer Institute CCOPs, the Credit Value and Type are now displayed on the Protocol Data Page Toolbox next to the Protocol Arm Identifiers and number of Patients:
Arm A (12 Patients) : 1.00 RX : 0.50 CC
7. The CURRENT STATUS REPORT has been modified to allow for multiple institutions to be included. Originally the user selected one institution from a popup box, and that was the organization that the Protocol Status Report was run against. Now, the user can select multiple institutions. When the report is created, the institution abbreviation is listed under the Status of each protocol. As an example:
Status: OPEN
JMWC
JMCC
8. There is an update to the Protocol Import module. At the point of importing, the user can IMPORT AS: and provide a new Identifier for the Study. As an example, a downloaded protocol may have the ID of: "NSABP-B-38" but the importing institution has a "stub" protocol "B-38". In the past, importing the protocol creates a new protocol "NSABP-B-38", when the desire was to have the protocol overwrite the original "B-38" keeping all the regulatory logs and staffing, simply appending the Arms with Schemas.
Now, on the Import screen there are 2 buttons: "Import Protocol" and "Import Protocol As:". Next to the second button is a text box for the user to enter in the Protocol Identifier of choice. In the case noted above, "B-38" would be entered into the text box, and "Import Protocol As:" would be clicked. The Importer would then locate the existing "B-38" study and prompt the user to overwrite it, thus preserving all Regulatory Reviews and Revisions.
In conclusion, an imported study can be renamed at the time of import.
9. The HIPAA Audit Log now includes the institution associated with the patient.
IDEA:
See CREDIT items: 1, 2, 3, 7, 8, 9
IRBANA:
See CREDIT items: 8
1. In the File Operations > System > System Variable Defaults Values > #54 the Variable Show Central IRB Associations Option on Data Page can be Enabled, Disabled. By default, it is Enabled.
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01/07/2006
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CREDIT:
1. On the IRB Follow-up Sheet for each protocol, there is a new column in the Revision Log table:
Reconsent Patients Yes\No
2. Component organizations that belong to a centralized IRB can now be allowed to see the Protocol Status Notes for the IRB Institution. As an example, if Hospital A is the IRB for several components, they have Status notes such as this:
"12/8/2005: Study opened per Hospital A IRB."
Hospital B, who participates with the Hospital A for IRB may have Status Notes:
"December 16, 2005 Hospital B has this study open."
Until now, each organization ONLY saw their own notes. However, often the IRB Hospital (A here) might want other institutions see the Hospital A notes. Now it can be done, and requires a System Variable to be Enabled:
File Operations > System > Edit System Variable Default Values > #52: Show IRB Status Notes To Components on Data Page If Enabled, the dual notes will display.
3. When Add\Editing an Agent for a Protocol Arm Segment, the Agents already listed may be changed to a different agent name. This does have limitations! If IDEA is installed, see IDEA #2.
4. When entering a participant into Pre-Study, the Name boxes are now titled with First Middle Last.
5. On the Pre-Study page, Protocol Workups now include the display of the Screening Notes.
6. On the Pre-Study Listing Report, both Patient Notes and Workup Notes are now available.
7. On the Patient Protocol Page (Event Focus), if IDEA is installed, the inventory list for each agent is now hidden behind the name of the drug. Clicking on the drug name opens up the inventory for viewing.
8. The Pre-Study Patient Workup page now allows for the selection of a Disease Site. That selection is echoed in the Pre-Study Listing Report. Please keep in mind that File Operations > System allows for Enabling a separate Disease Site directly on the Pre-Study Data Page. Most organizations have this disabled. This new feature allows for specific selection of Disease Site per workup.
9. When recording a Patient Adverse Event, if the Optional, Extended Reporting system is Enabled (System), the extended information will be displayed on Memorandum Prints and Emails. Please note: the characters "%" and "&" are illegal in the body of text in memo fields for email transmission. Using these characters will truncate the body of the email at the point the invalid character is entered. No error message is displayed.
10. Editing Email addresses for Patient Adverse Event Reporting is now available in File Operations > Patients >
Edit Agency for Adverse Event Notification
Changing the email addresses in this file will impact all future emails sent through the Patient Adverse Event Reporting System.
11. The Protocol Current Status Report now allows for DISTINCT entries when using a date range. This allows for pulling all protocols that have had an OPEN Status sometime during the date range. The Initial Review Date is a new column for inclusion.
12. Inside of each protocol, the Mini-Menu now has a new module to access: ORC: Recordings. The module must be Enabled in File Operations > System > System Variable Default Values > #17. This new module allows for maintaining a Preliminary Status log and ORC Date.
13. There is a new method of applying payment in the Financials Module. The new process allows for application of a check to specific invoiced items. The payment can also span multiple studies.
14. Each staff member can now have a Submissions Log. The entries for the types of submission are controlled in File Operations under the STAFF Anchor: Add Submission for Staff. By default, this table has been pre-loaded with:
Dr.,NCI,NCCTG,ECOG,SWOG,NSABP,RTOG,GOG,CTSU,COG
These are then available from each staff assignment page via a new button: STAFF SUBMISSIONS. This new popup allows an historical log of all submissions made to organizations.
15. There is a new report in the IRB Column: ORC Recordings. This is the report in support of #12 above.
IDEA:
See CREDIT items: 1, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
1. When Add\Editing an Agent for a Protocol Arm Segment, the Agents already listed may be changed to a different agent. This does have limitations! The name can only be changed if IDEA is not currently using the drug in a DAR. In that case, the Agent Name cannot be changed.
IRBANA:
See CREDIT items: 11, 12, 13, 14
1. In the Protocol Current Status Report, multiple Departments can now be selected for inclusion.
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