Composition of the data monitoring committee, its role and reporting structure {21a}
EVENTS, RECRUITMENT
The DSMB will be responsible for safeguarding the interest of trial participants, assessing the safety and efficacy of interventions during the trial and for monitoring the overall conduct of the clinical trial. The DSMB will provide recommendations about stopping or continuing the clinical trial. To contribute to enhancing the integrity of the trial, the DSMB may formulate recommendations relating to the selection, recruitment, and retention of participants, their management, and improving adherence to protocol-specified regiments and procedures for data management and quality control. The key responsibilities of the DSMB are as follows:Reviewing the study protocolEvaluating the quality of ongoing study conduct including accrual rate, adherence to protocol, accuracy, and completeness of data captureAssessing safety and efficacy data by intervention groupThe members of this DSMB are professor Lars Køber (chair), professor Nico Pijls, and professor Steen Dalby Kristensen. The DSMB will receive data from an unblinded independent data manager, Emil Fosbøl, who will not be involved in any other aspects of the trial. All meetings will comprise an open meeting (including the steering committee) and a closed meeting (DSMB alone). The DSMB may ask for additional data and events at the discretion of the DSMB.The DSMB will provide the principal investigator with a written report following every DSMB meeting. The DSMB may ask the steering committee to provide additional data (baseline and outcomes, etc.) before the report is finalized. The DMSB meetings will be held in person or via teleconference.