Protocol Review and Monitoring System

ABSTRACT: PROTOCOL REVIEW AND MONITORING SYSTEM The UNC Lineberger Comprehensive Cancer Center’s Protocol Review and Monitoring System (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 Resource and Feasibility Team (RAFT) followed by formal scientific review by the Protocol Review Committee (PRC). The PRC is chaired by Autumn McRee, 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 RAFT 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 2019, the PRC reviewed 392 protocols: 156 new studies and 236 active trials for renewal and monitoring. This represents an 8% increase over the PRMS activity at the time of our last renewal and reflects both our growth and dedication to an effective PRMS process.