CORE--PROTOCOL REVIEW AND MONITORING SYSTEM

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The Protocol Review Committee (PRC) of UPCI is responsible for reviewing all clinical cancer research studies conducted at the University of Pittsburgh and UPMC, prior to initiation of the study. The UPCI Data Safety and Monitoring Committee (DMSC) is responsible for the safety, validity of data, appropriate closure of trials, and monitoring of UPCI clinical research. In January 2002, the PRC expanded to three committees. Committees A and B, each meets once a month, in order to facilitate prompt review of cancer treatment protocols. Committee C is responsible for reviewing all behavioral and cancer epidemiology, cancer prevention and control, and complemcntary medicine protocols. The PRC evaluates each protocol,to ensure appropriate study design and scientific quality, availability of outside and/or institutional resources allocated, fiscal accounting of the utilization of resources, insurance billing and third party coverage issues. Following PRC review, documentation is recorded in the UPCI Clinical Trials Management Application (CTMA). This database also includes documentation of all appropriate regulatory approvals.