Composition of the data monitoring committee, its role, and reporting structure
ADVERSE EVENTS, EVENTS, EVENT, ADVERSE EVENT
Safety oversight will be provided by a DSMB. The DSMB consists of 5–7 expert members and are independent of study personnel. The DSMB will consist of members with expertise related to the trial. The DSMB meetings will be run via teleconference. If members are unable to participate, they will be replaced with another member with similar expertise. The DSMB will review study collected data and events every month including enrollment, demographics, compliance, and adverse events. The DSMB can also meet ad hoc in the event of an unanticipated significant adverse event. The DSMB independent study statistician, will have access to unblinded study data to evaluate these criteria. A final data review meeting will occur 2 to 4 months after study completion to review the cumulative safety data. Additional data can be requested by the DSMB as they deem requisite. The DSMB may share de-identified reports with participating/collaborating sites and/or institutions.