PROTOCOL REVIEW AND MONITORING SYSTEM PROJECT SUMMARY The Protocol Review and Monitoring System (PRMS) has been the internal review and monitoring system for all cancer clinical trials conducted at Yale Cancer Center since 1993. The PRMS provides a centralized mechanism for evaluating the scientific merit of clinical trials at YCC, and serves as the primary scientific review system for all cancer-related protocols prior to approval by the Yale University Institutional Review Board. The PRMS Specific Aims are to: 1. Provide scientific review of the clinical trials performed at the Yale Cancer Center;; 2. Set priorities for clinical trials at the YCC based on scientific merit and portfolio prioritization;; 3. Review progress of the trials for conduct and accrual. This grant period has seen the realization of many exciting PRMS accomplishments, most of which have been in response to the incredible growth of cancer research at Yale, the renewed focus on translational research, the unprecedented recruitment of new clinical research faculty, and the expansion of the clinical trials program. Selected accomplishments include: recruitment of new administrative leadership to support the PRMS;; enhanced biostatistics support with the formation of the Yale Center for Analytical Science (YCAS);; implementation of the OnCore Clinical Trials Management System (CTMS);; and restructuring of our scientific progress and accrual review system which will allow opportunities for extension of studies into Smilow Care Centers, affiliates, and collaborations with other institutions. Additionally, under sponsorship of the Office of the Yale Provost and the YCC Director, the IMPACT consulting group was engaged to completely review all aspects of the clinical protocol approval and activation processes at Yale University in mid-2016, with the goal of redesigning the business processes necessary to move a protocol from the conceptual stage at DART review to the point where it is open to accrual for patients. All steps related to protocol review and approval, including YCC committees, IRB, specially focused regulatory committees, budget, contracting, and EMR templating, were dissected for maximum efficiency. Prior to IMPACT, the existing state required 33 weeks median time to protocol activation, with numerous processes existing outside YCC and without overall coordination. The newly designed process for more concurrent upfront review is being piloted with 15 studies in early 2017. This process will have a central office to manage the overall process, greater personnel, and more concurrent processes to reduce the activation time to 18 weeks or less.