Video: When is a Clinical Data Safety and Monitoring Board (DSMB) Required?

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In this informative video, Tawnya Meier, Associate Medical Director–Safety at NAMSA, explains when a Data Safety Monitoring Board (DSMB) is necessary in clinical research—and why it plays a critical role in protecting patient safety and ensuring study integrity.

What You’ll Learn:

  • DSMB Basics: What a DSMB is and the role it plays in clinical trials
  • When It’s Required: Key criteria that trigger the need for a DSMB, including study risk level, complexity, and regulatory expectations
  • Regulatory Perspective: How FDA guidance influences DSMB requirements and what sponsors should consider during study planning

Whether you’re designing a high-risk study or navigating regulatory expectations, this video offers clear, expert-driven guidance to help you determine when a DSMB is essential.