A reportable event is any event that the IRB may determine is an unanticipated problem involving risks to subjects or others or serious or continuing noncompliance with the federal regulations or Institutional Review Board requirements.
During a study, you must promptly communicate any reportable events (e.g., adverse events, protocol deviations, noncompliance, etc.) to the IRB within 5 business days.
Reportable events are submitted to the IRB via Kuali Protocols. Instructions for creating a Reportable Event submission in Kuali Protocols can be found in the Kuali Protocol instructional guides.
The HRPP Guidance on Reportable Events provides information about which events should be promptly reported and which events should be reported with the study's next renewal or at study closure.
When IU's Human Research Protection Program (HRPP) receives a reportable event submission, staff will verify whether the event information meets prompt reporting criteria. If it does not require prompt reporting, HRPP staff will confirm that the event should be reported at the next renewal or study closure and withdraw it from further separate review. If the item does require prompt reporting, HRPP staff will prepare the information for review by the convened IRB.
If you have a question regarding what category an event should be reported under, whether the event is promptly reportable, or if other IU institutional policies may apply, please contact the HRPP.
