One component of a Safety Monitoring Plan may consist of an independent Data and Safety Monitoring Board or Committee. An independent Data and Safety Monitoring Board (DSMB) is required by NIH Guidelines for all Phase III clinical trials.

Studies that involve vulnerable populations, are blinded, and are considered to be of high or significant risk may also require a DSMB, depending on the nature and complexity of the study.

The primary purpose of an independent DSMB is to protect the research subjects through independent analysis of emerging data from the trial. This differs from adverse event reporting in that the DSMB can review aggregate and unblinded data as the data accumulate, identify significant issues and trends during the study, and recommend changes in the study including recommending early termination of the study.

The DSMB reviews data for both safety and efficacy. The protections afforded by this review apply to both current subjects and future subjects if the DSMB identifies the need to modify or even halt the trial. In addition, an independent DSMB protects the credibility of the trial by virtue of its independence from the study sponsors, and helps to ensure the validity of study results by reviewing data on subject accrual and conducting interim reviews.