[英文释义] 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.
This prospectie, randomized study was approed by the institutional reiew board for human research and was conducted under the auspices of an independent safety, efficacy, and data monitoring committee 这项前瞻、随机研究由人体研究制度审查委员会批准并受一个独立的安全、效验和数据监测委员会管理。