data monitoring committee (DMC)
Glossaries
| Term | Definition |
|---|---|
| data monitoring committee (DMC) |
Group of individuals with pertinent expertise that reviews on a regular basis accumulating data from an ongoing clinical trial. The DMC advises the sponsor regarding the continuing safety of current participants and those yet to be recruited, as well as the continuing validity and scientific merit of the trial. NOTE: A DMC can recommend stopping a trial if it finds toxicities or if treatment is proved beneficial. [After FDA guidance on establishment and operation of clinical trial data monitoring committees]
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Synonyms:
Data and Safety Monitoring Board; DSMB |
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