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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:

  • Define adverse event (AE).
  • Define serious adverse event (SAE).
  • Define life-threatening event.
  • Define unexpected adverse event.
  • Define suspected adverse reaction (SAR)
  • Define unexpected adverse device effect (UADE)
  • Describe what to assess when evaluating an adverse event.
  • Describe appropriate documentation of an adverse event.
  • Describe common data elements typically captured on case report forms.
  • Define when an Investigator is to report an adverse event to the sponsor in an expedited manner.
  • Define when a Sponsor is to report an adverse event to the FDA in an expedited manner.
  • Define what types of events are reportable to the Institutional Review Board (IRB).

 

Required   

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

 

 

 

Last updated by Ness, Elizabeth (NIH/NCI) [E] on Jul 24, 2016