Data and Safety Monitoring Board (DSMB)

The data and safety monitoring board (DSMB) is an independent committee that reviews the clinical study data to evaluate for participant safety and monitors progress, efficacy, and scientific validity. A data safety monitoring board is usually not required for all clinical trials but is recommended for trials that compare mortality or major morbidity.

The DSMB is made of a panel of medical professionals and biostatisticians (at least one) who lend their expertise to the study. None of the members can be directly involved with the conduct of the study and there should be no financial or non-financial conflicts of interest. Members are usually chosen by the sponsor and/or trial steering committee. In addition to their monitoring responsibilities, the DSMB can recommend that a trial be stopped early due to concerns of participant safety or if the main research question has been answered with the data gathered to that point.

Source: Data and Safety Monitoring Board (DSMB) Guidelines. (n.d.). NIH National Institute of Dental and Craniofacial Research. Retrieved January 8, 2022, from