K5. Data Safety Monitoring Board (DSMB)

A safety committee can be established to monitor the safety of the participants during the study. This can also be useful or appropriate for studies other than with medicinal products.

The EMA guideline on Data Monitoring Committees (EMA/CHMP/EWP/5872/03) covers information on when a safety committee is needed and provides information on the establishment of a DSMB and their working procedures.

If a safety committee is to be established for a study, the composition and charter of this committee needs to be submitted and approved by the reviewing MREC. The MREC can ask for establishment of a DSMB when deemed appropriate. The DAMOCLES Study Group published a template for a DSMB charter (Lancet 2005;365:711- 722).

An unsigned copy of the charter can be submitted as part of the primary submission. However, a signed version must be made available to the reviewing committee before approval can be given. Any previous advice of the safety committee or advice given during the review process of the MREC can be included under section K5 of the research file (advice given during the study falls under section L5 of the file: ‘Advice Data Safety Monitoring Board’).