DSMBs (also called DMCs) are common in Phase 3 trials, high-risk Phase 1/2 studies, and any trial with planned interim efficacy analyses. The DSMB charter defines membership, meeting frequency, and stopping rules.
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Glossary Term
Data and Safety Monitoring Board (DSMB)
Data & Safety
Also known as: DSMB, DMC, Data Monitoring Committee, Data and Safety Monitoring Committee
An independent committee that monitors accumulating safety and efficacy data in an ongoing trial and can recommend modification, continuation, or termination.
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