PROTOCOL REVIEW AND MONITORING SYSTEM: ABSTRACT The Protocol Review and Monitoring System (PRMS) oversees and ensures the scientific merit, appropriate resourcing, and progress of all cancer-related clinical studies at The University of Kansas Cancer Center (KUCC) and its consortium partners. PRMS evaluation occurs prior to submission to the Institutional Review Board (IRB), and does not overlap with its responsibilities. The PRMS has two stages of review: 1) the Disease Working Groups (DWG; report to the Associate Director (AD) for Clinical Research, Weijing Sun, MD, FACP; and the Executive Resourcing Committee (ERC; Tara Lin, MD, Chair, reports to AD for Clinical Research); and 2) the Protocol Review and Monitoring Committee (PRMC; Qamar Khan, MD, Chair, reports to the Deputy Director, Andrew Godwin, PhD). DWGs set priorities and portfolio needs, ERC evaluates feasibility and resources, and PRMC performs an independent scientific review. This two-stage process is formally recorded to maintain prompt activation of high priority studies and aligns with the CCSG guidelines. The PRMS process is aligned to ensure protocols receive high-quality peer-review and monitoring, and the research portfolio is consistent with KUCC clinical research priorities and catchment area needs. The 16 DWGs meet monthly for the initial review of scientific merit and available patient resources. The DWGs use a scoring system to prioritize studies, including disease specific needs. Highest priority is given to funded investigator-initiated, peer-reviewed trial proposals. DWG co-chairs are appointed by the AD for Clinical Research. Although the DWG composition is rich in clinicians focused on treatment trials and primarily Drug Discovery, Delivery and Experimental Therapeutics program members, members of Cancer Prevention and Control and Cancer Biology are also part of the DWGs. DWGs are evaluated yearly by the AD for Clinical Research for proportion of trials that are IIT and/or national, quality, translational nature of interventional trials, trial accrual, and national meeting presentations and publications. This data is used to further support areas of need as well as allocate staffing resources to growing and productive teams. The ERC reviews trial feasibility and resource assessment, protocol resource requirements, and available funding. The CTO sends DWG/ERC approved studies to the PRMC for scientific review. The PRMC performs independent scientific and biostatistical reviews, and adequacy of the data safety monitoring. The PRMC also monitors active protocols at least annually for scientific progress and accruals and terminates studies as appropriate. In 2020, the PRMC reviewed 287 new studies, 259 were approved and 15 were tabled and nine disapproved. In 2020, the PRMC reviewed 403 ongoing studies, 49 were placed on probation and 15 were terminated. In August 2020, PRMS was integrated into the Velos eResearch Clinical Trial Management System resulting in improved t...