Protocol Review and Monitoring System

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PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS) ABSTRACT The objective of the JCCC Protocol Review and Monitoring System (PRMS) is to ensure that all UCLA clinical cancer studies apply sound scientific approaches to produce meaningful results for the JCCC, cancer and scientific communities, providers, and most importantly for patients in and around the JCCC catchment area, Los Angeles County (LAC). Under the purview of the JCCC Director, Michael Teitell, MD, PhD (CMINT), the PRMS has oversight of all oncology-related clinical research conducted at UCLA. This oversight includes interventional, non-interventional, and some more basic science cancer studies. The PRMS performs rigorous scientific review of studies involving human subjects or specimens, including, but not limited to, treatment, prevention, diagnosis, screening, and other interventions. The PRMS works to assure that clinical studies are appropriately prioritized and utilize available JCCC resources and guidance efficiently. Over the prior project period, JCCC leadership revised the PRMS structure and functions. The core of the PRMS remains the Internal Scientific Peer Review Committee (ISPRC), under the authority of the JCCC, established in 1993. The ISPRC serves as the JCCC protocol review and monitoring committee (PRMC). As part of the reorganization of the PRMS, in further alignment with NCI-guidelines and meeting the needs of JCCC investigators, the newly appointed Director of PRMS, John Glaspy, MD, MPH (STT), established a two-stage review process for all JCCC institutional interventional trials. This process involves a new committee, the Institutional Protocol Committee (IPC), which conducts an initial review of JCCC institutional trial concepts or protocols prior to ISPRC submission. Only studies that receive IPC approval move forward for review by the ISPRC. This process began in early 2019 as a pilot looking at the completeness, efficiency, and quality of study submissions to the ISPRC. Once submitted to the ISPRC, members review the research protocol and associated scientific approaches, statistical approaches, patient populations, and JCCC resources required for study execution including staffing, expertise, clinical research facilities, and any necessary infrastructure. Of equal importance is ISPRC review of on-going interventional trials to ensure study progress, appropriate execution, and timely patient accrual to meet study endpoints. As part of study progress review, the continued scientific contribution of the clinical trial is also considered. The ISPRC may request ad-hoc reviews of trials or researchers based upon reports or identified issues related to trial execution according to the protocol and regulations, which may possibly nullify data, results, and ultimately scientific contribution. The PRMS provides complimentary and necessary, but non-overlapping, functions to the institutional review board (IRB).