- 《英文msh詞典》Data and Safety Monitoring Boards
- [同義詞] Data and Safety Monitoring Boards
- [主題詞] Clinical Trials Data Monitoring Committees
- [中文釋義] 數(shù)據(jù)和安全監(jiān)測委員會
- [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.
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