Reporting Unanticipated Problems and Adverse Events
Use the Event Reporting Form to report to the IRB unanticipated problems and adverse events involving risks to participants or others. Unanticipated problems and events should be reported no later than 7 days of the investigator becoming aware of the occurrence. However, investigators should contact Research Compliance Services (RCS) immediately upon discovery of an unanticipated problem or event involving risks to subjects or others.
For additional information on unanticipated problems, please see the Federal guidance which can be found at the Office for Human Research Protections (OHRP) website.