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Data Safety Monitoring Boards (DSMB)

Data Safety Monitoring Board or Committee (DSMB or DSMC), is a group of individuals with clinical expertise in the areas of the diseases or treatments administered as part of a research study.  Often these committees also include biostatisticians, clinical research experts and research ethicists. This committee functions as an independent group tasked with the responsibility to continually review the safety of the research study.  Through this review, they also assess the scientific integrity and validity of the research study. This group can make recommendations on the conduct of the study to the IRB, Investigator and Sponsor.

The level and frequency of review should correlate to the level of risk involved with the research study.  Per FDA guidelines, a formal DSMC/ DSMB should be established for studies where mortality and morbidity are primary data endpoints. For multi-center cooperative group and industry sponsored research studies, the sponsor is responsible for creating an independent DSMC/DSMB. For trials of lower risk to participants, the Data and Safety Monitoring Plan (DSMP) may only require the Principal Investigator (PI) at the site to monitor the safety and scientific validity of the study at regular intervals.

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