PROTOCOL REVIEW AND MONITORING SYSTEM (Core-010)

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Harold C. Simmons Cancer Center Protocol Review and Monitoring System (PRMS) Project Summary/Abstract The goal of the Protocol Review and Monitoring System (PRMS) is to ensure the highest scientific quality of clinical oncology research at UTSW and consists of three Cancer Center Protocol Review and Monitoring Committees (PRMCs), the Data and Safety Monitoring Committee (DSMC), and the administrative support services of the Clinical Research Office. These entities are overseen by the Clinical Cancer Research Committee, which reports to the Cancer Center's Deputy Director. The SCC has three PRMCs; two “general” committees, each of which meets monthly, and one reserved for Population Studies. PRMC1 and PRMC2 have the same responsibilities, but were created with staggered meeting dates so as to allow more timely review and approval of new protocols. The Population Sciences PRMC is responsible for protocols related to Population Sciences and Cancer Control. The three PRMCs review and monitor all cancer-related clinical studies for scientific merit prior to IRB review. The PRMCs have the authority to open protocols that meet the scientific merit and scientific priorities of the SCC, and to close protocols that do not demonstrate scientific progress. The focus of the PRMCs is on scientific merit, study prioritization, and progress of Cancer Center clinical trials. Studies which have already undergone rigorous peer review at the national level, such as NCI-approved national cooperative group studies are reviewed administratively by the PRMC Chair.