Clinical Trials Data Monitoring Committees

**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.

**Tree numbers:** - N05.700.685.149

**Synonyms:** - Data and Safety Monitoring Boards - Data Monitoring Committees - Safety Monitoring Boards