When do I report a protocol deviation to the IRB? Do I need to report a summary of deviations at the time of continuing review?

Question:

When do I report a protocol deviation to the IRB? Do I need to report a summary of deviations at the time of continuing review?
—Independent Research Center

Response:

For protocol deviations, reporting to WCG IRBs is required only for deviations that harmed a subject or placed subject at risk of a deviation made without prior IRB approval to eliminate an immediate hazard to a subject.

Our Promptly Reportable information form (downloadable here) includes a listing of events that you are required to report to WCG IRBs. You can use this list to guide your decisions about what kind of events require reporting.

Once you have reviewed the criteria for reporting and you still have questions about the reporting requirements, you should reach out to your point of contact at WCG IRB for the specific study or contact WCG client services. They would be in the best position to offer advice for a protocol specific question. Their contact information is: WCG IRB Client Services at 855-818-2289, or e-mail [email protected].

Regarding continuing reviews (CR), our CR form ask the following question: “Is there any information that required reporting per IRB ‘POLICY: Prompt Reporting Requirements’ that has NOT yet been reported to this IRB? So, at the time of continuing review you would report only those deviations that meet the threshold for reporting (defined above) and that had not been previously reported to the IRB.

Note that IRBs’ reporting policies may vary; so, be sure to check in with your IRB if WCG is not the IRB of record for your study.