The Data Safety Monitoring Board (DSMB)

Last revised: 

DSMBs are made up of multidisciplinary members who are knowledgeable in the conduct of research, and should include those with backgrounds in biostatistics, experimental design, bioethics, and experts in the medical field of concern.

DSMBs are responsible for reviewing data and endpoints on a timeline set forth by the DSMP in the protocol, and are typically required for the following types of studies:

  • More than minimal risk 
  • Multiple study sites. It is more difficult to recognize a pattern of increased or unusual problems when investigators treat small fractions of the population separately
  • Vulnerable population (pediatric, geriatric)
  • Blinded studies 
  • New therapies or science 
  • Highly toxic therapies or dangerous procedures.
  • High expected rates of morbidity or mortality in the study population.
  • High chance of early termination of the study.

Need assistance or have clinical study management questions?
Please contact CTSI Design Services