HRPP Policy - Reportable Events

About This Policy

Effective date:
Last updated:
Policy Contact:

IU Human Research Protection Program (HRPP)
(317) 274-8289

7.0 - Definitions related to this policy

adverse events, audit, authorization, confidentiality, continuing noncompliance, device, enrollment, HIPAA, human subject, humanitarian use device, informed consent, institutional review board (IRB), interaction, intervention, life-threatening, major protocol deviation, minor noncompliance, noncompliance, privacy, protocol deviation, regulatory agencies, related or possibly related, reportable event, research, research personnel, serious adverse event (SAE), serious noncompliance, suspension, termination, unanticipated adverse device effect, unanticipated problem involving risks to subjects or others (UPIRTSO), unexpected adverse event (UAE), written/in writing


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