Ask the Experts: 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 IRB is required only for deviations that harmed a subject or placed a subject at risk of a deviation made without prior IRB approval to eliminate an immediate hazard to a subject.

Our Promptly Reportable Information Form (HRP-204) includes a listing of events that you are required to report to WCG IRB. 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. You can call WCG IRB Client Services at 855-818-2289 or email at [email protected].

Regarding continuing reviews (CR), our CR form asks 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 IRB’s reporting policies may vary so be sure to check in with your IRB if WCG is not the IRB of record for your study.