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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