Question:

Do post marketing safety reports need to be reported to the IRB?  Am I required to submit post marketing Suspected Unexpected Serious Adverse Reaction (SUSAR) reports to the IRB?
– Manager, Pharmacovigilance, CRO

Response:

WCG IRB requires reporting of only those INDs safety reports that prompt a change to the protocol or consent document. We have based our guidance on the most current FDA recommendations, and it is our goal to try and encourage submission only of the items required and to avoid submission of non-reportable events, which causes delays in review and detracts from our mission of human participant protection. The FDA Guidance states the following:

“In general, an AE observed during the conduct of a study should be considered an unanticipated problem involving risk to human subjects, and reported to the IRB, only if it were unexpected, serious, and would have implications for the conduct of the study (e.g., requiring a significant, and usually safety-related, change in the protocol such as revising inclusion/exclusion criteria or including a new monitoring requirement, informed consent, or investigator’s brochure).”

FDA Guidance

Regarding post-marketing reports, if the product is marketed (in US or somewhere else) and used in a study overseen by WCG IRB, we’d want post-marketing reports if they indicated new risks.  For example, a SUSAR from one study not overseen by WCG with drug X could indicate an unanticipated risk to subjects for all studies with drug X, some of which WCG does oversee. While in practicality SUSARs are usually not reportable in and of themselves, the information that the sponsor is analyzing from the accumulation of information from them could be.

It is also important to note that WCG IRBs require reporting to the IRB of any findings from a closed study when the findings materially affect the safety and medical care of past patients.  Findings should be reported for up to two years after the closure of the study.