Incident Reporting and Compliance

This video reviews the regulatory requirements for reporting unanticipated problems to OHRP, including how to determine when an unanticipated problem or adverse event must be reported. (November 10, 2020)

Watch: Reporting to OHRP (1): Unanticipated Problems (18:05)

Director of OHRP's Division of Compliance Oversight, Kristina Borror, discusses how to respond to allegations of noncompliance and how to prepare for an investigation. (Feb 23, 2012)

Note: This video was created before the 2018 revisions of the Common Rule and may include information that is not up to date.

Watch: When the Feds come a' Knockin': How to Prepare for an OHRP Compliance Evaluation of your Program