ABSTRACT – PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS) The protocol review and monitoring system (PRMS) for the O’Neal Comprehensive Cancer Center (O’Neal) ensures that clinical cancer research performed at the University of Alabama at Birmingham (UAB) has scientific merit, is aligned with the priorities of the center, and progresses timely to yield relevant results. Fifteen disease working groups (DWGs) form the foundation of PRMS and serve as the primary setting for interface with the center research programs and the first step of scientific review of protocols. DWGs facilitate protocol development and perform scientific and feasibility review for internally and externally sourced clinical protocols. During the current project period, the DWGs reviewed 857 and approved 643 (75%) clinical protocols. Clinical protocols approved by the DWGs proceed for review by the Protocol Review and Monitoring Committee (PRMC), the second step of scientific review. The PRMC is composed of two co-chairs, administrative staff, and 17 core members representing several disciplines relevant to clinical cancer research. Following strict criteria, protocols undergo expedited review by co-chairs or full board review. The PRMC has final authority on protocol approval or rejection. While the PRMC and UAB’s Institutional Review Board (IRB) are independent with no overlapping membership, PRMC scientific approval is required for IRB approval. During the current project period, the PRMC reviewed 694 protocols, including 410 protocols that underwent full committee review. The PRMC oversees the progress of approved protocols towards their accrual goals. Following a well-established set of criteria, PRMC flags protocols for remediation when not meeting accrual goals and, in the event of inadequate improvement, determines the closure of protocols. In the current CCSG cycle, 300 protocols required PI action due to insufficient accrual. In 250 protocols, an adequate correction action plan was implemented while 50 were eventually closed by determination of the PRMC. The PRMS is supported by administrative staff that ensures uniform and consistent operation of DWGs and the PRMC, documentation of activities, and communication with investigators and research teams. Several important changes were implemented in the PRMS during the current period, including standardization of DWG activities, transition to fully electronic protocol management, implementation of virtual meetings, and establishment of dedicated administrative support. Operational improvements can be exemplified by the reduction in time from PRMC submission to determination (from median of 47 to 26 days). Future plans include increasing the interaction between DWGs and O’Neal research programs and aligning the DWGs with the Cancer Service Line to ensure synchrony between research priorities and clinical operations.