CORE--PROTOCOL REVIEW AND MONITORING SYSTEM

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The principal component of the UNC Lineberger's Protocol Review and Monitoring Systems is the Protocol Review Committee (PRC), chaired by Dr. Tom Shea. The 28-person PRC meets bi-weekly and reviews every cancer-related clinical trial protocol before it is submitted to the OHRP-approved UNC School of Medicine Committee for the Protection of the Rights of Human Subjects (IRB). The PRC's primary function is to ensure the scientific quality and patient safety of proposed studies and determine study priority. The PRC also monitors study accrual and recommends closure of under-performing trials. The PRC works with the Data and Safety Monitoring Committee (DSMC) and the Oncology Protocol Audit Committee (OPAC) on review of patient safety and the proper conduct of a trial. Overall PRC use has been relatively steady or slowly growing over the past five years. While the number of new protocols reviewed has been relatively constant, the complexity of the studies has increased. With a continuing strategic emphasis on clinical research, novel therapeutics, and behavioral interventions, the Center expects increases in the number of new clinical trials initiated at UNC LCCC, as well as a continued increase in the quality, complexity, and intensity of the current trials. In addition, the Center has formalized a Phase I Developmental Therapeutics group under the leadership of Dr. Claire Dees. These trends will increase the number of new trials coming to the PRC and continue to increase the number of renewal applications.