Protocol Review and Monitoring System

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Protocol Review and Monitoring System Principal Investigator: Pestell, Richard G., M.D., Ph.D. (P30 CA056036) PROJECT SUMMARY (See Instructions): PROTOCOL REVIEW AND MONITORING SYSTEM The Protocol Review and Monitoring System (PRMS) of the Kimmel Cancer Center (KCC) is an integral component of the KCC clinical investigations activities. The KCC PRMS is named the Cancer Clinical Research Review Committee (CCRRC). The CCRRC reviews all new research proposals involving human subjects and neoplastic diseases. Protocols receive a first review by the pertinent Multidisciplinary Disease Group, which provides a written evaluation of protocol feasibility, lack of competitive protocols or stratification if overlap with other protocols exists, and compatibility with KCC research and accrual goals. This evaluation is signed off by the specific Multidisciplinary Disease Group Leader. The Clinical Research Management Office (CRMO) staff prepares the documentation and coordinates meetings and communications for the CCRRC. The specific aims of the CCRRC are: (1) to maintain a review committee of Kimmel Cancer Center investigators (with representation from basic science and clinical areas) responsible for the initial scientific review and monitoring of all ongoing clinical trials; (2) to evaluate the scientific merit of new proposals (study value, methods, statistical merit, investigator experience, and patient resources); (3) to establish criteria for the prioritization of competing Kimmel Cancer Center studies; (4) to monitor trials for patient accrual metrics; (5) to maintain a collaborative relationship with the Thomas Jefferson University Institutional Review Board and the Kimmel Cancer Center Data and Safety Monitoring Committee (DSMC) to facilitate interaction between the three review committees; and (6) to assure protocol compliance through the monitoring of ongoing review scientific progress. The CCRRC initial scientific review of each proposed study focuses on: (1) study value; (2) methods; (3) investigator(s) experience (4) risk and (5) data and safety monitoring plans.