Composition of the data monitoring committee {21a}
stroke
STROKE, EVENTS
An independent external international scientific advisory board will be associated with the BOSS-STROKE trial that will provide scientific guidance, and will also take responsibility as the Data Safety and Monitoring Board (DSMB). Six researchers with international renowned expertise in stroke trials and/or rTMS treatment and an independent biometrician have agreed to participate in the board. The DSMB will be informed of all safety-related events by the PI. The DSMB will meet in regular intervals every 12 months and monitor the safety and adequate course of the clinical trial. It has also to decide whether reasons for premature termination of the clinical trial have occurred (see also above, criteria for discontinuing or modifying allocated interventions). Based on its review the DSMB will provide recommendations regarding trial modification, continuation or termination. The DSMB members will have access to the unblinded data if deemed necessary for their evaluations. The DSMB Charter is available for review upon request at the coordinating study center.