8.1 Review of Adverse Events and Adverse Device Effects

1.0 Purpose

The purpose of this policy is to describe the process for reporting research related Adverse Events (AEs) and Adverse Device Effects (ADEs) to the ORA and the IRB, and the process for review of AEs and ADEs.


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 Investigator Responsibilities


5.0 ORA Responsibilities


6.0 IRB Responsibilities


7.0 Reporting AEs/UADEs to Institutional Officials, OHRP, FDA, and Department or Agency Heads

All required reports will be submitted in accordance with HRPP policy 8.7 (Reporting Incidents to Institutional Officials and Federal Agencies).


DOCUMENT HISTORY:

 Written: 1/18/2016 (Approved: 1/18/2016) - original author not recorded

 Revised: 11/27/2017 - revision not documented

 Revised: 5/4/2023 - Clarified investigator responsibilities for reporting AEs that occur on studies for which the Organization is relying on another IRB; deleted expectation that reportable external AEs be followed by change request (since such AE reports often are made in the context of a change request) (section 4.2.1); stylistic changes.{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}


Revision #5
Created 24 October 2019 21:43:56 by Autumn M Eberly
Updated 17 February 2025 16:25:27 by Robert A Lewis