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Data Monitoring Committee (DMC)

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Also referred to as a Data and Safety Monitoring Board (DSMB) or Data and Safety Monitoring Committee (DSMC), a Data Monitoring Committee is a group of individuals independent of the investigator with pertinent expertise that reviews on a regular basis accumulating data from one or more ongoing clinical trial(s). The DMC advises the sponsor regarding the continuing safety of participant(s) and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the study. FDA: Guidance for Clinical Trial Sponsors, Establishment and Operation of Clinical Trial Data Monitoring Committees


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