Experts in Medical & Radiologic Imaging
RADIOLOGY
SECOND OPINION
Medical Conditions
Data and Safety Monitoring Boards
Committees established to review interim data and efficacy outcomes in CLINICAL TRIALS. The findings of these committees are used in deciding whether a trial should be continued as designed, changed, or terminated. Government regulations regarding federally-funded research involving human subjects (the "Common Rule") require (45 CFR 46.111) that research ethics committees reviewing large-scale clinical trials monitor the data collected using a mechanism such as a data monitoring committee. FDA regulations (21 CFR 50.24) require that such committees be established to monitor studies conducted in emergency settings.
