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Clinical Trials Data Monitoring Committees
Data and Safety Monitoring Boards | Safety Monitoring Boards | Data Monitoring Committees | Board, Safety Monitoring | Boards, Safety Monitoring | Committee, Data Monitoring | Committees, Data Monitoring | Data Monitoring Committee
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. |
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