Clinical Trials Data Monitoring Committees

Engelsk definition

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.

Svenska synonymer

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Engelska synonymer

Data Monitoring Committees — Committee, Data Monitoring — Committees, Data Monitoring — Data Monitoring Committee — Monitoring Committee, Data — Monitoring Committees, Data — Safety Monitoring Boards — Board, Safety Monitoring — Boards, Safety Monitoring — Monitoring Board, Safety — Monitoring Boards, Safety — Safety Monitoring Board — Data and Safety Monitoring Boards