CLINICAL PROTOCOL AND DATA MANAGEMENT: PROJECT SUMMARY Part I: Clinical Protocol and Data Management (CPDM) The CPDM Office at the Georgetown Lombardi Comprehensive Cancer Center (LCCC) is comprised of 209 FTEs, providing centralized research support to more than 95 LCCC clinical investigators across three clinical sites: MedStar Georgetown University Hospital (MGUH) and MedStar Washington Hospital Center (MWHC) in the District of Columbia (DC), and John Theurer Cancer Center (JTCC) of Hackensack Meridien Health (HMH) in New Jersey (NJ). The CPDM Office provides central management and oversight for coordinating, facilitating, and reporting on cancer clinical trials for LCCC, and education and training of research staff and clinical investigators. It functions as the interface with the Protocol Review and Management System (PRMS), Data and Safety Monitoring Committee (DSMC), Institutional Review Board (IRB), budget and contracting offices at Georgetown University Medical Center (GUMC) and JTCC, Office of Research Quality Assurance (ORQA), disease groups (DGs), and protocol sponsors to ensure high-quality, safe, and compliant clinical trial conduct. The CPDM Office services include comprehensive study activation and regulatory support from protocol conception to closeout, Investigational New Drug support, investigator-initiated trial (IIT) development and conduct, new trial registration, patient screening, registration and trial participation support, financial management, data management, and assistance with reporting of results through abstracts and peer-reviewed publications. The CPDM Office ensures real-time ClinicalTrials.gov trial registration and maintenance. The CPDM Office provides comprehensive reports and performance metrics to LCCC leadership for oversight and strategic planning including process improvement efforts. Over the project period, the CPDM Office reported accruing 11,196 subjects to clinical research studies conducted within LCCC (5,783 interventional and 5,413 non-interventional), including 1,073 interventional and 691 non-interventional accruals in 2022. Part II: Data and Safety Monitoring (DSM) DSM efforts include a multipronged approach of quality assurance and quality control at the protocol and institutional level. A DSM Plan is required for all interventional studies. For LCCC IITs, an LCCC-established DSMC performs real-time monitoring to ensure subject safety, scientific validity, and data integrity. Effective quality control functions are also instituted to ensure the highest level of protocol compliance according to the LCCC’s NCI-approved DSMP. Part III and IV: Inclusion of Women, Minorities, and Individuals Across the Lifespan in Clinical Research CPDM supports the LCCC and Community Outreach and Engagement priorities to proactively promote the recruitment of women and underserved populations. In 2022, among the 1,073 individuals enrolled onto interventional studies, 64% were women and 48% represented ethnic and ...