Research Roadmap

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 need for a DSMB is determined on a case-by-case basis. A complete, independent DSMB is generally not required or sensible for phase I medicinal product studies with extra supervision or an internal safety committee, or for ‘negligible-risk' studies. Researchers are responsible for setting up a DSMB, although in some cases the MREC may require one based on its own risk assessment.

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 a central DSMB pool for studies classified as ‘high-risk’ sponsored by Amsterdam UMC. The organization of these DSMB meetings is managed by CMC. Please contact CMC for assistance via:rs-dsmb@amsterdamumc.nl 

For further information, see:

• GCT SOP 05 Central DSMB Amsterdam UMC
• Chapter 8 of the NFU Guideline Quality assurance of research involving human subjects
• Data Safety and Monitoring Board (DSMB) (in Dutch).