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Glossary Definition

A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The group can recommend to the study sponsor that the study be stopped if it is not effective, is harming participants, or is unlikely to serve its scientific purpose. Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also referred to as a data safety and monitoring board (DSMB). (See also Data Monitoring Committee data element on ClinicalTrials.gov.)