Clinical Trials Data Monitoring Committees definition

Clinical Trials Data Monitoring Committees
Data Monitoring Committees; Board, Safety Monitoring; Boards, Safety Monitoring; Committee, Data Monitoring; Committees, Data Monitoring; Data Monitoring Committee; Monitoring Board, Safety; Monitoring Boards, Safety; Monitoring Committee, Data
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.