K5. Data Safety Monitoring Board (DSMB)
A Data Safety Monitoring Board (DSMB) can be established to monitor the safety of the participants during the study. A safety committee 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 review committee. The review committee 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 review committee before approval can be given.
Any previous advice of the safety committee or advice given during the review process of the review committee 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’).
Advice Data Safety Monitoring Board
Results of interim safety analyses by a safety committee and the advices of this committee concerning the continuation of the study, including the accompanying letter of the sponsor.
In general the DSMB advice will only be sent to the sponsor of the study. Only when the sponsor decides not to fully follow the advice of the DSMB, must the sponsor send the advice to the MREC. In the accompanying letter the sponsor has to substantiate why (part of) the advice will not be followed. In specific situations, when the MREC feels reasons for this, the sponsor can be asked to send all DSMB advices to the MREC.