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. |