HRPP Policy - Reportable Events

About This Policy

Effective date:
Last updated:
Policy Contact:

IU Human Subjects Office
(317) 274-8289

7.0 - Definitions

adverse event, audit, authorization, confidentiality, continuing noncompliance, device, enrollment, HIPAA, humanitarian use device, informed consent, interaction, life-threatening, major protocol deviation, minor noncompliance, noncompliance, observed or apparent noncompliance, privacy, protocol deviation, regulatory agencies, related or possibly related, reportable event, research, research personnel, serious adverse event (SAE), serious noncompliance, serious problem, 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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