The Continuing Review Form in iRIS will be updated to a new version on Monday, December 18th. For guidance about continuing reviews, please visit the IRB’s Continuing Review page.
What are the main changes?
New:
- Questions about study activities at relying sites, for studies where UCSF is the IRB of Record for external sites
- Questions about progress and future plans for studies in “Data Analysis Only” phase
- Ability to close a study via the Continuing Review Form, if it meets eligibility for closure
Revised:
- Many questions have been reworded for clarity
- Improved guidance has been incorporated where applicable
Removed:
- Modifications and personnel changes are no longer allowed at the time of continuing review. While only ~19% of continuing review submissions incorporate changes, they account for the majority of study expirations because they often require a more comprehensive review involving stipulations and revisions. After December 18th, study teams must submit modifications and personnel changes separately from the Continuing Review submission, once the renewal has received approval
What studies will be affected?
This change impacts studies that have an annual continuing review requirement. Look up your study in iRIS; If it has an expiration date, then it requires continuing review.
- If you start your continuing review submission prior to December 18th, iRIS will provide you with the current Continuing Review Form. You do not need to update it to the new version, even if you submit it after the 18th.
- If you start your continuing review submission on or after December 18th, iRIS will provide you with the new version of the Continuing Review Form.
What actions must the study team take?
None. iRIS will automatically provide you with the correct Continuing Review Form.
If you have questions about this bulletin, please contact the IRB office by submitting an Ask Andy form.