Data Safety and Monitoring Boards for Clinical Trials

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