Protocol Review and Monitoring System

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PRMS Summary The Protocol Review and Monitoring System (PRMS) provides essential support for the research mission of the FHCRC/UW Cancer Consortium in conducting clinical research. Results of this research help to define the best ways to prevent cancer and to treat and care for those affected by cancer. PRMS activities help ensure that efforts focus on protocols of the highest quality and most innovative character. These activities also help ensure that cancer patients served by the Consortium have opportunities to participate in studies matching the types and stages of diseases that occur in this population. The PRMS ensures that cancer- relevant human research is scientifically important, has a sound biostatistical foundation and supports the research mission of the Consortium. The PRMS also ensures that research is designed appropriately without excluding special populations for non-scientific reasons and is feasible, with reasonably attainable accrual targets given the available patient population. The Scientific Review Committee (SRC) has the primary role in the PRMS. Members of the SRC have deep, multidisciplinary expertise, including medical oncology, surgical oncology, radiation therapy, pediatrics, nursing, pathology, laboratory sciences, cancer imaging, pharmacy and biostatistics. Portfolios of research protocols are organized and maintained by defined Research Groups, each led by a senior faculty member. The SRC conducts an independent review of all new protocols and has well-defined approval criteria designed to ensure that goals of the PRMS are met. The SRC also reviews accrual and scientific progress for each study at 6-month intervals in order to ensure efficient use of resources, using well-defined approval criteria for continued accrual. Allowances are made for trials that focus on a rare disease or condition, those that are narrowly targeted, for investigator- initiated trials that have outstanding scientific merit, and for multi-site trials that are making adequate overall progress even if enrollment at the Consortium is low. The PRMS complements, but does not overlap with the functions or role of the IRB, which functions independently and is focused on human subjects protection.