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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