Adverse Events

Identifying and monitoring adverse events (AEs) is critical to protecting research participants and ensuring quality data. This module will provide an overview of AEs, including assessment, documentation, recording, and reporting including non-AE that are reportable to the IRB. The module is divided into 4 required components (videos) and 1 recommended video. Once you have completed all 4 required parts, please link to the evaluation after which you will be directed to a certificate of completion for your education records. 

Module Objectives

At the conclusion of this module, learners will be able to:



Part 1 

Part 2

Part 3

Part 4

AE Definitions (12 minutes)

AE Assessment and Documentation (20 minutes)

AE Reporting for IND and IDE Trials (17 minutes)

Event reporting to the IRB (19 minutes) 

Part 1 handout

Part 2 handout

Part 3 handout

Part 4 handout

 Resources Evaluation
Office for Human Subjects Protection: Reviewing and Reporting Unanticipated Problems and Adverse Events (25 minutes)