With the launch of Toolkit in early 2021, guidance on when to submit continuing reviews was updated:
If your study requires continuing review, you must submit your continuing review no later than 45 days (previously 60 days) prior to the study’s expiration date to allow sufficient time for IRB review. Unlike other IRB submissions, which are reviewed in order of submission, continuing reviews are reviewed based on the expiration date of the study. The change in submission guidance is being made to review continuing review applications sooner upon their submission to the IRB Office while not cutting off the study’s review period. This guidance applies to continuing reviews that require full committee review and those that qualify for review under expedited procedures.
The IRB makes every effort to review continuing review applications prior to a study’s expiration date. However, it is the study team’s responsibility to submit their continuing review application with sufficient time for IRB review.
Some additional continuing review reminders/notices:
- A continuing review application and a change of protocol can be submitted at the same time in ARROW and reviewed concurrently by the IRB.
- Continuing reviews for most Statistical Data Analysis Center (SDAC) studies, which previously could be expedited, now require review by the full committee at an IRB meeting.
- The guidance above applies to all continuing review applications, regardless of if the continuing review requires full committee review or can be reviewed under expedited procedures.