Reporting Unanticipated Problems and Adverse Events

Use the Event Reporting Form to report 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.

See the report new information (RNI) guidance on the RAP Guidance page for step-by-step directions on how to create and submit an RNI in the Research Administration Portal (RAP). 

For additional information on unanticipated problems, please see the Federal guidance which can be found at the Office for Human Research Protections (OHRP) website.

If you have questions, please contact Research Compliance Services.