Composition of the data monitoring committee, its role, and reporting structure {21a}
ADVERSE EVENTS, RECRUITMENT
The DSMC will provide safety and efficacy monitoring for the duration of the study. The DSMC consists of a group of multidisciplinary experts with experience in trial management and consists of a US-based orthopedic surgeon, a Tanzania-based emergency medicine physician, a PhD health services researcher, and a NIAMS-appointed safety officer. All DSMC members are independent of the study sponsors and both the coordinating and study site.The DSMC will provide recommendations on continuing or stopping of the trial. In addition, they may provide recommendations on recruitment, follow-up, and/or data management during the duration of the trial. The DSMC will have the power to prematurely stop the trial for considerations of safety or futility during their regular reviews of serious adverse events or interim analysis.