PROTOCOL REVIEW AND MONITORING SYSTEM PROJECT SUMMARY/ABSTRACT The Chao Family Comprehensive Cancer Center (CFCCC) Protocol Review and Monitoring System (PRMS) ensures rigorous internal oversight of the scientific aspects of all cancer-related, hypothesis-driven clinical research studies conducted at the University of California, Irvine. The Disease-Oriented Teams (DOTs) and Protocol Review and Monitoring Committee (PRMC) together comprise CFCCC's two-stage PRMS. The PRMS consists of qualified UCI faculty and staff with the necessary level of expertise within their respective scientific research areas. Committee membership is of sufficient size and breadth of expertise to provide oversight and review of all cancer-related research protocols. PRMS processes are governed by standard operating procedures and guidelines. The PRMS is facilitated and supported by the Sue and Ralph Stern Center for Cancer Clinical Trials & Research (Stern Center), the centralized office for clinical trial operations at the CFCCC. The first component of the CFCCC's two-stage review process, the DOTs, are multidisciplinary groups of basic, translational, clinical, and population health investigators who collaborate on a specific anatomic cancer area in order to further the translation of CFCCC discoveries through the pipeline towards interventional clinical trials. The focus of the DOTs is to ensure rigorous internal scientific review of protocols, manage the clinical trial portfolio, and drive innovation. The DOTs formally score protocols for prioritization based on investigator input, scientific merit, the potential for correlative science and academic credit for CFCCC investigators, study accrual potential, existence of active competing trials and whether the disease under investigation disproportionately affects minority populations in the CFCCC's Catchment Area. The DOTs also perform the assessment of scientific quality for NCTN and industry studies. The PRMC is responsible for the second stage of scientific and feasibility review of protocols and has the sole authority to authorize activation of clinical studies. The PRMC assesses scientific merit and quality for institutional investigator-initiated trials (IITs), determines if the CFCCC has the appropriate resources to support the trial and determines how the trial fits into the broader research agenda of the CFCCC. The PRMC is responsible for the continuing review of open protocols for scientific progress and has sole authority to close trials due to lack of progress, new safety information, or scientific relevance. The rigor of the CFCCC PRMS ensures the scientific quality and progress of clinical research conducted at the Cancer Center and the appropriate management of the Center's resources. The PRMS is critical to the CFCCC's mission to develop new knowledge about the causes, prevention, detection, treatment, and survival of cancer to shift scientific paradigms, change public policy and clinical practice, and...