This page provides information and general guidance about those events that need to be reported promptly to the IRB during the conduct of research activities. The regulatory term used for these events is Unanticipated Problems Involving Risk to Subjects or Others. Serious adverse events (SAE) are just one type of unanticipated problem that require prompt reporting due to their potential to place subjects or others at risk of harm.
IRB SOP 408: Unanticipated Problems Involving Risks to Subjects provides more detailed definitions and describes the required reporting criteria in detail. The IRB's policy conforms to the reporting requirements established in both OHRP's and the FDA's Guidance documents.
- OHRP: Guidance for Reviewing and Reporting Unanticipated Problems
- OHRP Video on Unanticipated Problems
- FDA: Guidance for Clinical Investigators and Sponsors on Adverse Event Reporting to IRBs
Keeping Track of Reportable Events
It is important to track all reportable events including SAEs, other unanticipated problems and protocol deviations. The following should be included:
- Subject ID
- Date of the event
- Date the PI became aware of the event
- Description of the event
- Date the event resolved (if applicable)
- Type of harm (if any) experienced by the subject
- Relationship harm to the event (causality)
- Date that report was submitted to the IRB and other regulatory authorities. Many events will not require a report other than at the time of continuing review.