This web seminar will describe what a Data Safety Monitoring Board (DSMB) — also known as a Data Monitoring Committee (DMC)—is, and how it’s constituted according to FDA and European Medicines Agency (EMA) requirements. We’ll cover the selection of the members and their duties and responsibilities, as well as when a DSMB/DMC is and is not needed. We’ll also take a look at the contents of a DSMB/DMC charter. Interim analyses (with and without statistical analyses) will be discussed, as well as looking at benefits and costs. DSMB/DMC actions and recommendations in terms of study change or termination will be reviewed. Problems, ethical issues, and potential conflict will be discussed, along with strategies for resolving them. Learners will come away with tips, war stories, and practical advice on making DSMB/DMCs work.
- Define a DSMB/DMC
- Describe when and how to set up a DSMB/DMC
- Identify risks, dangers, and benefits
- Define the operational aspects of a DSMB/DMC
- Clinical Trial (Phases I-IV) Physicians, Monitors, and Safety Coordinators
- Regulatory Affairs Personnel dealing with safety
- CROs and other support organizations working with clinical trial safety
- Quality, Risk, and Compliance Personnel
Barton Cobert, M.D., F.A.C.P., F.A.C.G.
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Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-14-076-L01-P. Released: 10/14.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.