Under the Revised Common Rule (RCR), expedited status studies initially approved after January 19, 2019, (and older expedited studies that switched to the RCR), are no longer required to undergo a complete continuing review. Those studies instead will get the two-question annual check-in form, which basically tells the IRB that the study is still a going concern, and that you’d like to keep it going.
We get asked a lot whether study teams should submit compilations of adverse events and deviations with those abbreviated forms. Since the studies are not subject to continuing review, those compilations are not required to be included with the 2-question continuing review forms. Requiring those forms kind of goes against the spirit of no longer requiring continuing review.
But — it’s critical that study teams continue to track adverse events and deviations internally. Only by tracking these items in real time will you notice patterns indicating a need to consider changing study procedures via a modification, or that would require reporting using a reportable new information form.