CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM): PROJECT SUMMARY Clinical Protocol and Data Management (CPDM) at Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) facilitates translational science by providing services that enable and promote the conduct of high- quality clinical research. These services include managing processes and providing expertise that enable high- quality protocol development and efficient trial activation, along with supporting the infrastructural elements of clinical research – finance, regulatory, data, and clinical research coordinator and nursing management – to promote WFBCCC science and its translation into the community and to promulgate NCI and Cancer Center Support Grant objectives for clinical research. CPDM also maintains a centralized protocol document directory, a centralized database of protocol-specific data, and data and safety monitoring activities that promote high quality performance and study completion while ensuring participant safety. Since CPDM’s consolidation shortly before the previous competing review into a fully centralized model, under the leadership of Stefan Grant, MD, JD, MBA, Medical Director of CPDM, a new clinical trial management system, OnCore®, has been fully implemented, the Florence® electronic regulatory binder system has been deployed, and staffing has been expanded. In the 2020 grant year, despite the COVID-19 pandemic, CPDM reported the recruitment of 14,022 accruals into all clinical research studies within WFBCCC, including 424 accruals into interventional treatment trials, and facilitated the activation of 95 new studies. A Data and Safety Monitoring Plan is required for all interventional studies. For WFBCCC investigator-initiated studies, risk-based monitoring is conducted by the Data Safety Monitoring Committee (DSMC) to ensure the highest levels of patient safety. Effective quality control functions are also instituted to ensure the highest level of protocol compliance according to the 2021 WFBCCC’s NCI-approved DSM Plan. WBFCCC supports multiple proactive efforts to promote the recruitment of women and minorities in research. These efforts have included working with the Office of Cancer Health Equity to assess catchment area needs and launch initiatives to support underserved patients through education and navigation. In 2020, of all individuals enrolled into interventional and non-interventional studies, 57% were women, 3% Hispanic, and 21% were a racial minority. WFBCCC also supports the NIH policy on the inclusion of individuals across the lifespan in research. In 2020, 51 children and 266 adults over the age of 65 were enrolled onto interventional studies.