8.0 Abstract: Protocol Review and Monitoring System (PRMS) The Protocol Review and Monitoring System (PRMS) of the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) is a two-step system. Step 1 occurs at Disease/Modality Focused Group (DFG) meetings, where faculty and staff involved in specific disease teams discuss current and proposed clinical trials. Step 2 involves the Clinical Research Committee (CRC) which reviews all new cancer-related protocols for scientific merit, methodology, competing studies in the portfolio, and reasonability of accrual goals before submission to the Institutional Review Board (IRB). The CRC ensures an expert biostatistics review of clinical trial design and calculation of sample size for each institutional and selected non-institutional protocols. CRC reviews the Data Safety Monitoring plan to ensure sufficiency and receives DFG and UMGCCC Protocol Feasibility Committee input to ensure proper prioritization and utilization of resources. CRC continually reviews accrual to studies supported by UMGCCC and closes poorly accruing trials. Finally, CRC provides scientific review for issues that arise relating to accrual, safety or adverse events noted by the Data Safety Monitoring/Quality Assurance Committee, and addresses IRB questions. During the 2019 calendar year, the CRC performed full committee level reviews of 123 protocols; 71 were approved as written, 31 were approved with minor modifications, 15 were approved with major modifications requiring re-review, and 6 were deferred. An expedited review process exists for research that is deemed to pose minimal risk, based on University of Maryland–Baltimore IRB guidelines, and that involves chart reviews, interviews or surveys, studies of archived biospecimens, collection/banking of biospecimens during routine clinical procedures, Phase III industry-sponsored trials, or any Phase IV postmarketing study seeking more information on safety and efficacy. During CY2019, expedited review approved 21 studies. To further refine the use of CRC resources, a new category of review (Acknowledgment Review) was created in 2019 to allow for UMGCCC CRC acknowledgment of research approved by the National Cancer Institute (NCI) Central Institutional Review Board (CIRB) or of studies that have undergone external peer review (e.g., approved by the PRMS of another NCI-designated cancer center or consortium trial). During CY2019, 172 trials were monitored for accrual and any protocols not accruing at a rate suggesting successful completion of targeted enrollment within three to five years were targeted for corrective action. In CY2019, UMGCCC received the “Most Improved” award, granted by Forte Research for achieving a 90-day reduction in overall trial activation including a 9-day reduction in CRC approval. Sixty-five warning letters were issued, resulting in closure of 11 protocols in CY2020. During FY2019, costs to support PRMS exceeded $800,000, of...