PROTOCOL REVIEW AND MONITORING SYSTEM: PROJECT SUMMARY The goal of the Protocol Review and Monitoring System (PRMS) is to provide independent peer review of the scientific merit, priority, feasibility, and progress of all clinical cancer research studies conducted within the Virginia Commonwealth University (VCU) Massey Cancer Center (MCC). PRMS functions are accomplished by rigorous evaluations through a multi-stage review process conducted by 1) MCC’s multidisciplinary Disease Working Groups (DWGs) that perform initial assessments of the value, fit, operational feasibility, and prioritization within the existing portfolio of studies; and 2) the Protocol Review and Monitoring Committee (PRMC), the definitive, independent authority for determining which studies proceed to activation based on scientific merit. DWG approval is required before proceeding to the PRMC; however, only the PRMC has final authority with regards to determining which studies will be activated. The PRMS process ensures that all MCC cancer-relevant research studies are 1) scientifically sound; 2) effectively designed, specifically from a biostatistics perspective; 3) appropriately prioritized within the DWG research portfolio to avoid competing trials and ensure alignment with MCC’s overall institutional priorities for clinical research; 4) feasible for activation and completion (or in meeting institutional target accrual goals); 5) assessed for data and safety monitoring adequacy based on the study risk level; and 6) monitored regularly for accrual and scientific progress. In 2021, the MCC DWGs vetted in aggregate 113 studies and forwarded 77 to the PRMC. Once received by the PRMC, 42 studies received an initial expedited review by the PRMC as they had already received an appropriate external scientific peer review, and 35 studies, primarily representing MCC’s investigator-initiated and industry-sponsored trials, were forwarded for full PRMC review. More than 20% (7/35) of the studies reviewed by the full committee required modifications prior to approval. None of the studies were disapproved, reflecting the effectiveness of the DWG vetting process and the attentive support investigators receive from the MCC Clinical Trials Office and MCC leadership in developing their investigator-initiated studies prior to PRMC submission. In addition, in CY2021 the PRMC performed scientific and accrual monitoring reviews for 152 studies. Of those, 59 studies received low accrual notifications requiring Principal Investigator response. This resulted in the closure of 14 studies. The PRMS, inclusive of the DWG and PRMC review processes, is one of the most critical functions that the MCC performs to ensure the highest quality clinical research is being conducted.