Protocol Review and Monitoring System

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PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS) – ABSTRACT The Protocol Review and Monitoring System (PRMS) at KCI ensures rigorous review of the scientific merit of research protocols, prioritization of protocols across the Cancer Center, and monitors progress of all clinical research. Prior to submission to the PRMC, a first stage review is conducted within each of the Multi- Disciplinary Teams (MDT), who prioritize protocols within their respective area of expertise and practice. With respect to prioritization of protocols, the MDT conducts a pre-review of potential protocols for activation to determine whether they complement the current portfolio of open protocols and whether they should move forward for submission to the PRMC. The MDT also reviews the protocols for scientific interest and the likelihood of attaining adequate accrual. This process eliminates redundant reviews by the PRMC and reduces submission of competing protocols. Although the MDT identifies the prioritization, it is reviewed and confirmed by the Protocol Review and Monitoring Committee (PRMC). The PRMC fulfills the primary role of the PRMS. The PRMC is composed of a broad array of complementary expertise with an emphasis on senior investigators from various disciplines and specialties, as well as representatives from the Biostatistics and Bioinformatics Core, Pharmacology and Metabolomics Core, the Clinical Trials Office (CTO), the KCI Network, and the Office of Cancer Health Equity & Community Engagement. 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. 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.