Unanticipated Problems

This policy describes the events that require prompt reporting to the IRB, and sets out timelines for reporting.  The policy offers many examples of problems or events requiring prompt reporting to the IRB.

***The revised policy will take effect on September 1, 2026. Until that date, the previous version of the policy should continue to be used and followed. Beginning September 1, 2026, the new policy will supersede the previous version.