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Course Overview

Duration:

This course should take 30-40 mins to complete.

Certification:

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

Summary:

This course outlines the role of a Data Safety and Monitoring Board (DSMB) during a clinical trial. Appointed by the trial's sponsors, the DSMBs are responsible for assessing the overall progress of the trial and focusing in particular on analysing the safety and efficacy data. Working within a regulatory framework, this analysis aims to monitor the participants for any adverse effects and assesses when the endpoint of the research has been reached. This course is aimed at anyone involved with DSMBs and clinical trials.

Objectives:

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

  1. What a Data Safety Monitoring Board does
  2. The existing regulations and where the gaps are
  3. The statistical considerations involved
  4. A basic DSMB membership training curriculum
  5. Principles that should guide a DSMB

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:

The contents of this course are taken entirely from the paper: Lang T, Chilengi R, Noor RA, Ogutu B, Todd JE, Kilama WL, Targett GA. ‘Data Safety and Monitoring Boards for African Clinical Trials. Trans R Soc Trop Med Hyg. 2008; 102(12):1189-1194.

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.

Translation: Français