Research Roadmap

It may be necessary to set up a Data Safety Monitoring Board (DSMB) for the duration of the research project in order to monitor the safety of the participants involved, evluate the efficacy (if applicable), and the overall conduct of the project.

A DSMB is an independent committee of experts that carries out assessments at fixed times to ensure that the balance between clinical utility and the demands on study participants remains at an acceptable level during the research phase, and to advise whether modifications are necessary for the study’s progress.

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

Amsterdam UMC offers a central DSMB pool for studies with a high risk classification (see chapter 4 Risk Management of the NFU guidelines for Quality Assurance of research involving human subjects) sponsored by Amsterdam UMC. The organisation of these DSMB meetings, planning etc. is delegated to CMC. Please contact CMC for questions and/or assitance through: rs-dsmb@amsterdamumc.nl 

For further information see GCT SOP 05 Central DSMB Amsterdam UMC