Protocol Review and Monitoring System (PRMS) The Protocol Review and Monitoring System (PRMS), called Protocol Review Committee (PRC) at the University of Pittsburgh Cancer Institute (UPCI) has responsibilities before and after trial activation. In the narrative it will be referred to as PRC/PRMS.
The specific aims of PRMS are to: 1) Provide scientific review of clinical protocols before submission to the Institutional Review Board (IRB), 2) Monitor open clinical trials for ongoing scientific merit and scientific progress, and 3) Close trials that fail to meet benchmarks for continued scientific merit and timely accrual. Prior to trial activation, PRC/PRMS reviews each protocol for scientific quality and priority. Once open, PRC/PRMS monitors each trial for ongoing scientific merit and progress. The goal of Protocol Review and Monitoring System (PRMS) is to promote the highest scientific quality and ensure efficient conduct of cancer clinical trials at UPCI and UPMC CancerCenter (UPMC CC). Clinical research is a tightly coordinated activity at UPCI where Clinical Protocol and Data Management (CPDM), the Data and Safety Monitoring Committee (DSMC) and PRC/PRMS work in concert. Importantly, the PRC/PRMS role in clinical research, to provide review and monitoring for scientific merit and progress, is distinct from the DSMC responsibility to ensure protocol safety and data quality. The PRC/PRMS also works in conjunction with three other parts of the clinical trials enterprise, the University of Pittsburgh IRB, the UPCI Biostatistics Facility, and the UPCI Disease Center teams. PRC/PRMS includes four committees (Committees A, B, C, and E). Committees A and B each meet once a month (off cycle) to provide coverage every 2 weeks to facilitate prompt review of cancer treatment protocols. Committee reviews all biobehavioral, cancer epidemiology, cancer prevention and control, and complementary medicine protocols as the need arises. Committee E was established in April, 2014 to provide Electronic review of industry trials, selected by the UPCI Director and/or Associate Director of Clinical Investigation, for expedited activation, for example, review of a study that uses a novel agent that might benefit a patient at UPCI and is already open at other sites. Membership of the PRC/PRMS includes a diverse group of cancer experts including medical, radiation, and surgical oncology, pharmacology, biostatistics, nursing, regulatory affairs, and laboratory scientists. PRC/PRMS members are appointed by the UPCI Director in consultation with the Associate Director for Clinical Investigation. The PRC/PRMS evaluates each protocol for study design, scientific quality, and availability of patient and financial resources required to complete the proposed trial. PRC/PRMS approval of cancer clinical trials is required before the study can be submitted to the University of Pittsburgh IRB, NCI CIRB or other accredited IRB. Once a trial is opened, the PRC/PRMS reviews for ongoing scientific merit and progress every six months. The PRC/PRMS has the authority to suspend or close any study that fails to meet the scientific requirements. Oversight for PRC/PRMS activities is provided by the UPCI Clinical Research Oversight Committee (CROC).
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