This webinar was presented live on Thursday, March 22, 2018. Click below to watch on demand.
This webinar will provide clinical research professionals with an understanding of safety oversight for clinical studies, including regulatory requirements and best practices. The presentation will include a discussion of the FDA’s Guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees, and help attendees understand the differences between Data Safety Monitoring Boards (DSMBs), Clinical Events Committees (CECs), and Medical Monitors. Professionals at research sponsors, CROs, sites, and IRBs will learn when each type of safety oversight is recommended and how to provide effective, efficient safety monitoring. Participants will also hear from a DSMB chair about their experiences and the important impact of safety groups to research studies.
After completing this webinar, you will understand:
- The roles of DSMBs, CECs, and MMs for Safety Monitoring
- The FDA’s expectations outlined in the Data Monitoring Committees guidance
- The importance of administrative support to providing effective, efficient safety monitoring