Data Monitoring Committee

Data Monitoring Committee (DMC; also known as Data Safety and Monitoring Board or DSMB) refers to a group of independent experts who are appointed to periodically review information from an ongoing clinical study, including participant’s safety, protection of confidentiality of participant data, and efficacy of the therapy. The findings of the DMC 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. U.S. Food and Drug Administration (FDA) regulations (21 CFR 50.24) require that such committees be established to monitor studies conducted in emergency settings.

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NCATS Toolkit for Patient-Focused Therapy Development: Data Safety and Monitoring Board