HRPP Policy - Reportable Events

About This Policy

Effective date:
07/19/2018
Last updated:
01/21/2019
Policy Contact:

IU Human Subjects Office
(317) 274-8289
irb@iu.edu

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
Back to top