《英文msh詞典》Data Monitoring Committees
[入口詞] Data Monitoring Committees
[主題詞] Clinical Trials Data Monitoring Committees
[英文釋義] 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.