Data monitoring committee (DMC)

A DMC protects subjects and the integrity of the study. Its independence from the sponsor is the point, so its charter and the data it sees should be set before the study starts.

independent (3.26) committee that can be established by the sponsor (3.49) to assess, at intervals, the progress of the clinical investigation (3.8), the safety data or the critical clinical performance (3.11) or effectiveness (3.20) endpoints (3.22) and to recommend to the sponsor whether to continue, suspend, modify, or stop the clinical investigation Note 1 to entry: For the purpose of this document, “data and safety monitoring board (DSMB)”, “data and safety monitoring committee (DSMC)" or "independent data monitoring committee (IDMC)” are synonymous with DMC.

ISO 14155:2020, clause 3.17

A group of individuals with pertinent expertise that reviews on a regular basis accumulating data from one or more ongoing clinical studies. A DMC may recommend that a study be stopped if there are safety concerns or if the study objectives have been achieved. Also sometimes called a Data Safety and Monitoring Board (DSMB).

FDA guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices (November 2013), Section 11, Glossary