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Regulations

Reviewing and Reporting Unanticipated Problems and Adverse Events

Michael Carome, formerly of OHRP, discusses the criteria for determining if an incident or outcome is an unanticipated problem involving risk to subjects or others (according to the HHS regulations), the differences between adverse events and unanticipated problems, and how to respond . (Jul 5, 2010)

Watch: Reviewing and Reporting Unanticipated Problems and Adverse Events