Protocol Review and Monitoring System

PROJECT SUMMARY A single Protocol Review & Monitoring System governs all oncology clinical trial protocols across the Fred Hutch/University of Washington/Seattle Children’s Cancer Consortium partner institutions derived and supported from institutional sources, including those originating from other cancer centers or from industry, and assures that cancer-relevant human research is 1) scientifically important and statistically sound; 2) designed appropriately without excluding specific populations for nonscientific reasons; 3) feasible, with reasonably attainable accrual targets given the available patient population; and 4) supportive of the research mission and the Consortium’s strategic priorities. A research group review is required prior to submission to the Scientific Review Committee (SRC) as part of a two-stage PRMS review process and assures that Consortium protocols are of high scientific merit, reflect the needs of the patient population and catchment area, and are feasible prior to investing additional institutional resources in development and implementation. As part of the Consortium’s trial activation process, SRC approval is required prior to IRB review. All protocols approved by PRMS have access to CCSG-supported centralized resources, including Clinical Protocol & Data Management and Consortium Shared Resources. The PRMS further ensures that once open, the trial’s accrual is sufficient to meet the scientific aims of the study and the scientific rationale remains relevant, per the stringent SRC Low Accrual Policy. This policy is supported by a rigorous review and closure process and is continuously assessed for efficacy. The SRC has the ultimate authority to close trials that do not demonstrate scientific progress.