Clinical Research Policy

NIH Data and Safety Monitoring Policies

Clinical trials must be conducted with a high standard of quality that assures the research question is answered in a reliable, valid, and unbiased manner, and that the rights and welfare of human subjects are protected. The safety of research participants in clinical trials must be monitored, potential harms must be minimized, and if the design of the study is deemed no longer appropriate, the trial must be discontinued.

In 1998, NIH issued a policy and further guidance was published in 2000.  The NIH Data and Safety Monitoring policy states that each NIH Institute and Center (IC) should have a system for appropriate oversight and monitoring of clinical trials in order to ensure the safety of participants and the validity and integrity of the data.  The NIH requirement for data and safety monitoring --at a level commensurate with the risks, size and complexity of the trial--is separate and distinct from the requirement for protocol review and approval by an Institutional Review Board (IRB).

The 1998 policy and 2000 guidance describe when monitoring should be conducted by a Data and Safety Monitoring Board (DSMB).  A DSMB is an independent advisory body of experts appointed to assess, at regular intervals, the progress of a clinical trial (or several trials), review accumulating data, evaluate adverse event reports, and determine critical efficacy endpoints in a manner that contributes to the safety of subjects and the continued validity and scientific merit of the trial.  The DSMB provides recommendations regarding study modification, suspension, or termination, as appropriate.  While all interventional studies are required to have a data and safety monitoring plan, the establishment of a DSMB to perform the monitoring function, at a minimum, is required for all multi-site clinical trials that pose risks to participants. Some IC policies specify other types of studies that must be monitored by DSMBs.