This release contains several improvements and resolves the following issues.
Human Subjects application
Q15.4 updated to: Are any of the listed drugs/biologics a controlled substance?
On the Conflict of Interest disclosure, question D1 was updated to include examples.
For IRB Staff
Changes to the list of Agenda Item Types for activities such as Full Committee:
- Added:
- Expanded Access Study
- Combined:
- “Deferred Study” & “Pending Clarification” (keeping “Deferred Study”, retiring “Deferred - Pending Clarification”)
- Removed:
- Re-submission
- Re-activation
- Final Reports
- HIPAA Requirement
- Discussion Items
- Previous Meeting
The Study Team Membership Lookup report now displays and can be filtered by the IRB with oversight.
Updated language in the Application, Amendment and Continuing Review No CR Required Notification Templates to state “The IRB has determined, consistent with 45 CFR 46.109(f), that annual continuing review is no longer required for this research.”
Amendment
The list of exemption categories has been updated on the Record Committee Decision activity. This category displays on the approval letter.
Continuing Review
“Not transitioning to new rule” was added as a CR Required Reason.
For Ancillary Committees
The Primary Investigator’s Administrative Home has been added to notifications.
For Protocol Review Committee
Updated editable determination letters:
- To all letters:
- Change "Theodore Lawrence" to "Anne Schott"
- Change "Comprehensive Cancer Center" to "Rogel Cancer Center"
- Change "Clinical Trials Office" to "Clinical Trials Support Unit"
- To Approve with Contingencies Letters:
- Change "four months" to "three weeks"