HRPP Policy - Reportable Events

About This Policy

Effective date:
07/19/2018
Last updated:
07/01/2021
Policy Contact:

IU Human Research Protection Program (HRPP)
(317) 274-8289
irb@iu.edu

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

 

View All Abbreviations and Definitions

Back to top