Composition of the data monitoring committee, its role, and reporting structure {21a}
death
ADVERSE EVENTS, EVENT
The data and safety monitoring board (DSMB) is established in order to monitor the safety of participants. The DSMB consists of two independent physicians and a statistician with pertinent experience who may review study information during the conduct of the trial. Their major responsibility is to make recommendations on further study conduct. Any premature termination or suspension of the trial must be discussed with the DSMB. The DSMB will review a safety event dossier, provided by the sponsor for all reported cases of severe adverse events and death.