Data Safety Monitoring Boards
Data Safety Monitoring Board or Committee (DSMB or DSMC) consists of experts in the field of research tasked with reviewing data integrity and safety
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.
Note: The DSMB template is only to be used after scheduling a regulatory consult with the DSMB Program Manager at the CCTS. Please email CCTS-Regulation. Scheduling a consult will allow for the use of the CCTS DSMB service, without completing a consult the DSMB service cannot be used.
- HRPP Policy on Data and Safety Monitoring
- The Ohio State University Comprehensive Cancer Center-James DSMP
- Center for Clinical and Translational Regulatory Knowledge: DSMP
- Center for Clinical and Translational Regulatory Knowledge: DSMB
- NIH: Guidelines for Data and Safety Monitoring
- NIH: Policies and IC Guidance for Data and Safety Monitoring of Clinical Trials
- FDA: Establishment and Operation of Clinical Trial Data Monitoring Committees