But there is a second obligation. The same event that triggers sponsor reporting may also trigger a report to the Institutional Review Board. And here is where I have watched even experienced coordinators hesitate -- because the IRB report is not a copy of the SAE form. It uses a different form. It follows a different timeline. It emphasizes different information. And the determination of whether this particular event requires IRB reporting at all depends on institutional policy, not on the sponsor's protocol.

The sponsor wants clinical detail: onset, severity, treatment, outcome, causality. The IRB wants something different. The IRB wants to know whether this event changes the risk-benefit equation for participants at this site, whether it constitutes an unanticipated problem, whether the research should be modified, whether currently enrolled participants need new information. Same event. Different questions. Different recipients. Different deadlines.

This lesson addresses the second stream -- the one that flows to your institution's IRB or ethics committee. If the prior three lessons in this module taught you how to process incoming safety information from the sponsor, this lesson teaches you when and how that information must go back out to the body that approved your research in the first place.

But there is a second obligation. The same event that triggers sponsor reporting may also trigger a report to the Institutional Review Board. And here is where I have watched even experienced coordinators hesitate -- because the IRB report is not a copy of the SAE form. It uses a different form. It follows a different timeline. It emphasizes different information. And the determination of whether this particular event requires IRB reporting at all depends on institutional policy, not on the sponsor's protocol.

The sponsor wants clinical detail: onset, severity, treatment, outcome, causality. The IRB wants something different. The IRB wants to know whether this event changes the risk-benefit equation for participants at this site, whether it constitutes an unanticipated problem, whether the research should be modified, whether currently enrolled participants need new information. Same event. Different questions. Different recipients. Different deadlines.

This lesson addresses the second stream -- the one that flows to your institution's IRB or ethics committee. If the prior three lessons in this module taught you how to process incoming safety information from the sponsor, this lesson teaches you when and how that information must go back out to the body that approved your research in the first place.