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Compliance In Focus
Posted by John Lehmann on Thu, Mar 15, 2018

Making Sense of Safety Oversight in Clinical Research Webinar

This webinar will provide clinical research professionals with an understanding of safety Safety Oversight Webinar.jpgoversight 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

The webinar is scheduled for March 22nd at 2:00 p.m. ET. Please sign up today.

Outsourcing Safety Management Checklist

 

photo credit: davidroethler IMG_20150304_152147 via photopin (license)

Topics: IMARC Research, Safety Oversight, Webinar

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