Data Safety Monitoring Board (DSMB)

  • WMO

A Data Safety Monitoring Board (DSMB) may be necessary for the duration of the study in order to oversee participant safety, evaluate efficacy (if applicable), and monitor the overall conduct of the study.

A DSMB is an independent committee of experts that assesses the study fixed times to ensure that the balance between clinical utility and the demands on study participants remains at an acceptable level. It also advises on necessary modifications for the study’s progress.

A DSMB typically includes a chairperson (a clinician), an epidemiologist or statistician, and one or more additional experts in the relevant professional field. DSMB members must be independent of the research team, which is confirmed in a signed statement of independence.

At Amsterdam UMC, a DSMB is mandatory for studies classified as ‘high-risk’. For studies classified as ‘moderate’, the PI/researcher may also set-up a DSMB but it is nog mandatory. For phase I medicinal product studies with extra supervision or an internal safety committee, or for ‘negligible-risk' studies a DSMB is generally not required or sensible. Researchers are responsible for setting up a DSMB.

The DSMB charter outlines the committees responsibilities, composition, meeting schedule, procedures, and decision-making process, and must be approved by the MREC.

Amsterdam UMC offers central support for methodology / epidemiology and statistics. Please contact the department Epidemiology and Data Science for assistance.

For further information, see: