PROTOCOL REVIEW AND MONITORING SYSTEM: ABSTRACT The Protocol Review and Monitoring System (PRMS) was first implemented in the early 1990s to oversee research involving cancer patients at KCI. The main objectives of the PRMS are to: 1) review the scientific merit of all cancer research protocols; 2) ensure prioritization of cancer protocols according to KCI's scientific priorities; and 3) monitor scientific progress. The Protocol Review and Monitoring Committee (PRMC) fulfills the primary role of the PRMS. The committee is composed of a complementary mix of investigators from various disciplines and specialties, as well as representatives from the Biostatistics Core, basic science, nursing and physician extenders, and administrative support staff from the Clinical Trials Office (CTO). The members of the committee represent a sufficient size and breadth of expertise to conduct a critical and fair scientific review of all clinical research protocols involving cancer patients at KCI. The PRMC provides internal oversight of the scientific merit of the cancer trials in addition to assuring that its clinical resources are engaged to ensure the best practices for scientific endeavors and applications. The function of the PRMC is complementary to that of the IRB, which focuses on the protection of human subjects. The PRMC is not intended to duplicate or overlap the responsibilities of the IRB, nor is it intended to perform an auditing or data and safety monitoring function. The PRMC evaluates all cancer clinical trials, whether derived and supported from NCTN, peer reviewed sources, institutional sources, or from industry. However, the PRMC does not duplicate the results of traditional peer review, which includes protocols supported by various NIH mechanisms (e.g., R01s, U01s, P01s, U10s and P50s), and clinical research protocols approved by the NCI's Cancer Therapy Evaluation Program. These trials are still reviewed for competing studies, feasibility and resource allocation. Scientific review takes into account the specific rationale, study design, duplication of studies already in progress elsewhere and at the Cancer Center, adequacy of biostatistical input, and feasibility for completion of the study within a reasonable time frame. Additionally, the PRMC is responsible for accrual monitoring; protocols are reviewed regularly to evaluate scientific progress, including accrual rates, to ensure that the scientific aims of the study are on track for completion in the estimated timeframes indicated at initial submission.

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