CLINICAL PROTOCOL AND DATA MANAGEMENT - PROJECT SUMMARY Part I: Clinical Protocol and Data Management (CPDM). CPDM for Yale Cancer Center (YCC) is accomplished through the Clinical Trials Office (CTO), which provides centralized services for conducting cancer clinical trials and supporting 14 Clinical Research Teams (CRTs) extending across 16 YCC/Smilow Network sites. The CTO encompasses all forms of CPDM support: protocol development, regulatory, enrollment, study coordination, data management, Investigator-Initiated Trials, training, and quality management. The CTO serves as the repository and reporting body for all clinical research protocols and data, supports all YCC clinical research committees, and facilitates representative recruitment of subjects in the YCC Catchment Area. While the CTO experienced destabilization due to the COVID-19 pandemic and its lingering consequences, substantial institutional support and commitment allowed the CTO to rebuild and recover. Accomplishments include 1) New medical and executive leadership, 2) Expanded training and quality management, 3) Optimization of staffing and reduction in staff turnover, 4) Enhanced organizational structure, 5) Improved workflows and processes and 6) Improved time to activation. The effects of these improvements have positioned the CTO to increase capacity, improve efficiency, and ensure sustainability in alignment with the Director’s vision and 2023 Strategic Plan. In FY23, the CTO reported the recruitment of 1040 individuals into all clinical research studies conducted at YCC, including 601 interventional treatment accruals, and has facilitated the activation of 99 studies. Part II: Data and Safety Monitoring (DSM). DSM is required for all interventional studies. YCC has an established DSM Committee (DSMC), which performs risk-based data and safety monitoring to ensure patient safety. Effective quality control functions provide the highest level of protocol compliance in accordance with YCC’s NCI-approved DSM Plan. In FY23, the DSMC monitored 180 studies, which included the review of 29 audits, 76 progress reports, and all reported deviations and serious adverse events. Part III: Inclusion of Women and Minorities in Clinical Research. YCC actively promotes the recruitment of women and minorities. In FY23, 56% of adults accrued to YCC interventional treatment trials were women and 20% were underrepresented ethnic and racial minorities; in both cases, these exceed the respective proportions of YCC’s analytic cases and those of YCC’s Catchment Area. Part IV: Inclusion of Individuals Across the Lifespan in Clinical Research. YCC supports the NIH policy on the inclusion of individuals across the lifespan in research. The percentage of accruals to interventional treatment studies for patients aged <18 increased over the project period (1.5% in FY18 to 2.2% in FY23). Children (age <18) accounted for <1% of YCC analytic cases, and 2.2% of total accruals (interventional and non- interve...