The Protocol Review Committee (PRC) of University of Pittsburgh Cancer Institute (UPCI) is responsible for reviewing all clinical cancer research studies conducted at the University of Pittsburgh and UPMC prior to initiation of the study. Its activities are overseen by the Clinical Research Oversight Committee (CROC) along with two other entities that work in parallel to orchestrate cancer clinical research, the Data Safety and Monitoring Committee (DSMC) and the Clinical Research Services (CRS). The PRC also works in conjunction with three other parts of the clinical trials enterprise, the University of Pittsburgh IRB, the UPCI Biostatistics Facility, and the disease-oriented management teams, to promote the highest scientific quality and most efficient conduct of cancer clinical trials at the UPCI. The PRC is comprised of three committees. Committees A and B each meet once a month in order to facilitate prompt review of cancer treatment protocols. Committee C is responsible for reviewing all behavioral, cancer epidemiology, cancer prevention and control, and complementary medicine protocols as the need arises. The PRC evaluates each protocol to ensure appropriate study design and scientific quality and availability of patient and fiscal resources required for successful completion of the trial proposed. Membership of the PRC includes a diverse group of cancer experts including hematology/oncology, surgical oncology, urologic oncology, pharmacology, biostatistics, nursing, regulatory affairs, and laboratory scientists. PRC approval of cancer clinical trials is required before the study can be submitted to the University of Pittsburgh IRB. All UPCI trials are reviewed for accrual every six months. Studies achieving less than 30% of target accrual are flagged for review. A notification letter is sent to the PI requesting a plan to increase accrual, and the study is re-reviewed for accrual in six months. To simplify documentation and monitoring of UPCI clinical trials activities, all formal committees (PRC, CROC and three DSMC) have a single recording secretary, who is responsible for recording the minutes of each meeting, and facilitates communication between the committees, University and UPMC regulatory committees, regulatory agencies, and UPCI PIs.
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