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You are watching: Reviewing and Reporting Unanticipated Problems and Adverse Events

Release date: 20/03/11 Duration:  25m 18s

Dr. Michael Carome, former OHRP Associate Director of Regulatory Affairs, is interviewed and discusses the criteria for determining if, in the context of human subjects research, an experience, incident, or outcome is an unanticipated problem involving risk to subjects or others, as described in the HHS regulations at 45 CFR part 46.

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