(PROTOCOL REVIEW AND MONITORING SYSTEM) The primary responsibility for the Protocol Review and Monitoring System (PRMS) rests with the University of Michigan Comprehensive Cancer Center (UMCCC) Protocol Review Committee (PRC). The PRC is aided in its pursuit of the PRMS Specific Aims by the Clinical Research Teams (CRTs) and the Scientific Progress Review Subcommittee of the PRC (SPRS-PRC), which have specific, non-overlapping, and well-defined roles. The PRC, which is comprised of experts in clinical research from diverse disciplines, provides independent peer review of the scientific merit and feasibility of new cancer-related clinical protocols. It also monitors the scientific progress of activated protocols to ensure that they continue to be of high scientific merit and priority, support the UMCCC research mission, and achieve accrual goals in a realistic timeframe. By providing this level of exceptional peer- review oversight of cancer clinical research at University of Michigan (U-M), the PRC helps to ensure that UMCCC conducts high quality protocols that are scientifically impactful, realize their accrual targets, and utilize UMCCC resources wisely (e.g., shared resources, UMCCC funds, and the Oncology Clinical Trials Support Unit (O-CTSU)). The CRTs are disease- and domain-oriented groups in the UMCCC that serve as the nidus for patient-oriented research. The teams are composed of multidisciplinary physicians, translational cancer research scientists, advanced practice providers, nurses, geneticists, clinical research coordinators, data managers, regulatory specialists, patient advocates, and others involved in the performance of clinical cancer research. CRTs are led by mid-career and senior clinical investigators who have an academic primary focus on clinical research, have significant experience as principal investigators on interventional cancer clinical trials (with particular emphasis on investigator initiated trials, or IITs), and see patients in the clinics associated with their respective disease team. The CRTs are charged with reviewing and prioritizing proposed cancer clinical trials within their respective disease/domain that arise from the scientific themes in the CC Programs and elsewhere, both to ensure scientific merit, and to increase the chances of success in implementation.
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