PROTOCOL REVIEW AND MONITORING SYSTEM (Core 019)

Abstract ? Protocol Review and Monitoring System (PRMS) The UNC Lineberger Comprehensive Cancer Center's PRMS facilitates internal oversight of the scientific aspects of all cancer clinical trials at the University of North Carolina focusing on the scientific merit, priorities, and progress of clinical protocol research. The system is a multi-step process with preliminary review by Protocol Office Disease teams (PODs) and the Protocol Office Executive Committee (POEC), followed by a formal review by the Protocol Review Committee (PRC). The PRC is chaired by Peter Voorhees, MD, and meets bi-monthly to review every cancer-related clinical protocol before it is submitted to The Office of Human Research Ethics' Institutional Review Board (IRB). The PRC's primary function is to ensure the scientific quality of proposed studies. As described in Clinical Protocol and Data Management (CPDM), PODs and POEC review protocols for feasibility, quality, and priority before they are submitted to the PRC. The PRC monitors study accrual and has the authority to close under- performing trials. During 2014, the PRC reviewed 295 protocols -- 112 new studies and 183 active trials for renewal and monitoring.