Clinical Trial Oversight: An Introduction to Data Safety Monitoring

All clinical trials require study oversight to ensure the rights and well-being of subjects are protected, data is accurate, complete and reliable, and that the trial is conducted in compliance with the protocol, ICH-GCP and applicable regulatory requirements. 

Study oversight can be completed in different ways and is outlined in the Data Safety Monitoring Plan (DSMP). Oversight may include the use of a Data Safety Monitoring Board (DSMB) or Data Safety Monitoring Committee (DSMC).  Attend this training to learn more about when a DSMB/DSMC is required; the objectives and responsibilities of a DSMB/DSMC; and what outcomes can result from a DSMB/DSMC meeting.

Presented by: April Green and Asia McDavid