Protocol Review and Monitoring System

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PROJECT SUMMARY: PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS) A single Protocol Review and Monitoring System (PRMS) governs all oncology clinical trial protocols across the Consortium partner institutions and assures that cancer-relevant human research is (1) scientifically important and statistically sound; (2) designed appropriately without excluding special populations for non- scientific reason; (3) feasible, with reasonably attainable accrual targets given the available patient population; and (4) supportive of the research mission of the Consortium. The central feature of the PRMS is the Scientific Review Committee (SRC). The PRMS committee structure is responsible for approving protocols that meet its stringent and well-defined criteria. A Research Group Review is required prior to submission to the SRC as part of a two-stage review process and assures that Consortium protocols are of high scientific merit and feasible prior to investing additional institutional resources in development. The SRC evaluates scientific merit, feasibility, prioritization, and progress of all Consortium clinical trial protocols. As part of the Consortium’s trial activation process, SRC approval is required prior to IRB review. Efficient operations and weekly SRC meetings have resulted in a median overall process time of 14 calendar days (10 business days) which has remained consistent since 2015. The PRMS further ensures that during accrual, the scientific rationale for the protocol has remained relevant and that accrual is sufficient to meet the scientific aims of the trial. Since implementation of the updated Low Accrual Policy in FY 2015, the number of reviews and closures increased from 25 trials reviewed and three closures, to 74 reviewed and 24 closed in FY 2018. All protocols approved by PRMS have access to CCSG-supported centralized resources, including Clinical Protocol and Data Management (CPDM) and the Biostatistics Shared Resource (BSR). PRMS has the ultimate authority to close trials that do not demonstrate scientific progress.