Course Overview

Duration:

This course should take 35-45 minutes to complete

Certification:

A certificate is issued once a minimum of 80% is achieved in the final quiz section.

Summary:

Adverse Events can be defined as undesirable or harmful effects or experiences arising or linked to the clinical research being carried out. This short course provides a general introduction and overview of Adverse Events and how to deal with them when they occur. This course is suitable for everyone involved in clinical research.

Objectives:

Upon completion of this course, you will have an understanding of:

  1. The importance of collecting, recording and reporting adverse events;
  2. The definition for the different categories of adverse events;
  3. The mechanisms used for identifying these events, how they are evaluated when they occur and how follow-up may be carried out;
  4. The necessity of assessing a causal relationship between the study intervention and the adverse event; and
  5. What data is typically reported and who receives the reports.

Acknowledgements

The Global Health Training Centre is built through the support and partnership of the Bill and Melinda Gates Foundation, the World-Wide Antimalarial Resistance Network and the East African Consortium for Clinical Research

Editor:

  • Mary Logan -  Global Health Network Training Manager

Reviewers:

  • Steve Wandiga - Kenya Medical Research Institute (KEMRI)/Centers for Disease Prevention and Control (CDC) - KEMRI/CDC Research and Public Health Collaboration, Kisumu, Kenya.
  • Andy Burke - CTSU, Oxford University

Funders:

This module has been funded by the WorldWide Antimalarial Resistance Network (WWARN).

Source Material:

This course is based on the material very kindly supplied by the Clinical Trials Support Office, MRC Unit, the Gambia from their taught course ‘Collecting and Recording Adverse Events.’

Use and reproduction of these elearning materials:

These e-learning materials are owned by The Global Health Network. You are free to share or adapt this material but you must attribute it to The Global Health Network using the link www.theglobalhealthnetwork.org.