PROTOCOL REVIEW AND MONITORING SYSTEM – PROJECT SUMMARY/ABSTRACT The University of Virginia Cancer Center (UVACC) conducts a robust two-stage review for rigorous internal oversight of the scientific aspects of all cancer clinical studies. The First stage review is via Disease Teams that are involved in trial selection, implementation, study coordination, and data management. Each disease team consists of disease-focused clinical research investigators (MD and PhD) and study staff involved in the development and conduct of clinical studies. Each disease team defines their clinical research priorities. The first stage review by disease teams helps eliminate many trials from moving forward in the start-up and implementation process. Second stage review is via the UVACC Protocol Review and Monitoring System, which oversees and ensures the scientific merit, priorities, and progress of all cancer clinical studies conducted at the UVACC. A Protocol Review Committee (PRC), appointed by the UVACC Director and administratively supported by the Office for Clinical Research, has been given the authority and charge to carry out this mandate. The PRC is chaired by Ryan Gentzler, MD. Its primary goal is to ensure that investigator-initiated and industry- initiated cancer research studies involving human subjects conducted at the UVACC are: (1) scientifically and statistically sound; (2) appropriately designed; (3) feasible for completion; and (4) in compliance with NIH guidelines for human studies. The PRC also plays an important role in mediating competing studies by requiring adherence to an institutional prioritization plan and patient availability, and closely monitors the clinical trial progress and rules for termination of studies in the UVACC based upon accrual and continued scientific relevance.