PROTOCOL REVIEW AND MONITORING SYSTEM - PROJECT SUMMARY The Yale Cancer Center (YCC) Protocol Review and Monitoring System (PRMS) is the internal, independent peer review and monitoring system for all cancer-focused clinical studies involving human subjects conducted across all sites at Yale University. The PRMS provides scientific review, prioritization, and ongoing scientific progress review and accrual monitoring, for alignment with the Center’s mission and goals within the catchment area and beyond. This is accomplished through an integrated two-stage process with Stage I conducted through 14 Clinical Research Teams (CRTs), where initial evaluation of scientific value, fit with the patient population, overlap with current studies, and prioritization within the current disease or modality portfolio is conducted along with operational feasibility and reasonableness of achieving accrual targets. Stage II is the role of the Protocol Review Committee (PRC), which provides the definitive determination of whether a protocol is approved, requires a response, or disapproved. The PRC membership is composed of highly qualified individuals across all disciplines required for effective review. The PRC is functionally subdivided into two committee panels which each meet biweekly. PRC leadership ensures consistency and quality across individual members and committee panels. The PRC has the final authority for approving cancer-related protocols and closing studies that are either not achieving their accrual goals or no longer meet scientific merit standards. It is the PRC’s responsibility to ensure that cancer-related studies are scientifically sound; well designed, including from a biostatistical perspective and inclusion of women, minorities, and individuals across the lifespan; appropriately prioritized; relevant to the mission of the YCC and its catchment area; assessed for risk and appropriateness of the data and safety monitoring plan; and monitored at appropriate intervals for accrual and scientific progress. Significant improvements during the project period include: 1) Implementation of a Study Prioritization Rubric to further standardize and add rigor to the first stage CRT review; 2) Implementation of a REDCap tracking system to improve recording and reporting of CRT review and determinations; 3) Expansion of PRC membership to form a second committee panel to improve time from submission to initial review; and 4) Streamlining of amendment reviews by PRC and IRB. In FY23, CRTs assessed over 400 studies, disapproved 65% and approved 35% to move to PRC. Of the 134 submitted to PRC in FY23, 26 received expedited review since they previously received appropriate peer review (e.g., NCTN), 100 studies received full PRC review and 8 administrative PRC review. In total, 118 (88%) were approved, 15 required a written response before approval, and one was disapproved. During this same period, PRC conducted on-going scientific and accrual reviews for 346 acti...