Data Safety Monitoring Board

A Data Safety Monitoring Board (DSMB) is a group of independent individuals, external to the trial, who are experts in relevant areas. They review the accumulated data from ongoing clinical trials on a regular basis and advise the sponsor about the continued safety of the trial participants, the continued validity of the trial or the continued scientific merit of the trial.

Although safety monitoring is an essential and integral part of any trial, not all clinical studies require a Data Safety Monitoring Board. The creation of a DSMB may be critical for studies that intend to save lives, monitor safety in case of long-term trials even in non-life-threatening diseases, and reduce the risk of a major adverse health outcome. DSMBs are particularly important in studies where interim data analysis is required to ensure the safety of research participants.