Terms of reference for Data and Safety Monitoring Committees.
The Data and Safety Monitoring Committee (DSMC) constitutes one of the most complex elements of a clinical trial. For this reason, it is critical that all participants in and contributors to a trial understand the functions and responsibilities of the DSMC. Failure to understand the complexity of this group's mission can lead to substantial opportunities for confusion among investigators, sponsors, regulators, and the public, especially if the trial that it monitors must be modified or terminated early.
Packer
M
M
Division of Circulatory Physiology, Columbia-Presbyterian Medical Center, 5-435, 177 Fort Washington Ave., New York, NY 10032, USA. mp65@columbia.edu
Wittes
J
J
Stump
D
D
D002986:Clinical Trials as Topic / Q000592:standards*; D003219:Confidentiality; D004282:Documentation; D017277:Drug Approval / Q000458:organization & administration*; D009316:National Institutes of Health (U.S.); D014481:United States