Here’s another reason to get your continuing review forms in early: The IRB now routinely closes studies once a continuing review (CR) has been expired for 30 days. Even studies that have a CR form pending, or that have contingencies outstanding from a pending CR form, are subject to closure if the approval has been expired for 30 days. You will be required to complete a Study Resumption form in CLARA to reopen the study. Once the Study Resumption form is processed, your next step will be to complete a CR form to renew the approval. When submitting that CR form, please remember to specifically state whether any activity occurred during the expired period. The IRB will need to know that information before it can process the CR form.
The expired period ends only after the new CR is approved; approval of the Study Resumption form does NOT mean that the study has been approved for another year.
Keep an eye out for the CLARA reminder letters sent 90, 60, and 30 days before expiration telling you CR expiration looms. You’ll also get a letter when the CR actually expires, which starts the 30-day clock ticking.