CLINICAL PROTOCOL AND DATA MANAGEMENT: PROJECT SUMMARY Part I: Clinical Protocol and Data Management (CPDM). The Clinical Protocol and Data Management Office (CPDM) in the Herbert Irving Comprehensive Cancer Center (HICCC) comprises 95 FTEs who provide centralized research support services to more than 50 HICCC members. These services include comprehensive regulatory support from protocol inception to activation. The CPDM is a unique entity at Columbia University Irving Medical Center (CUIMC) and NewYork-Presbyterian Hospital (NYPH). The CPDM also supports accruals to clinical trials, inclusive of all sponsor types, by providing centralized cores of trained clinical research nurses, clinical research coordinators and data managers to HICCC members. Research coordination and protocol compliance are enhanced through fostering a strong member-CPDM interaction, collaboration, and teamwork. As the central data repository of all oncology-related trial activities, the CPDM provides comprehensive reports and performance metrics to the HICCC senior leadership team (SLT) for proper oversight and strategic planning, including training and education initiatives (with the Cancer Research Career Enhancement or CRCE Core). The CPDM also ensures compliance with NCI’s Clinical Trials Reporting Program (CTRP) and ClinicalTrials.gov reporting requirements. In 2018 alone, the CPDM reported the recruitment of 6,262 individuals into all clinical research studies being conducted within the HICCC (710 interventional and 5,552 non-interventional accruals) and has facilitated the activation of more than 137 studies. Part II: Data and Safety Monitoring (DSM). DSM is required for all interventional studies. For the HICCC member-sponsored studies, the HICCC has established its own DSM Committee (DSMC), which performs risk- based monitoring to ensure the highest level of patient safety and data integrity. Effective quality control functions are also instituted as outlined in the HICCC’s NCI-approved DSM plan to ensure protocol compliance. In 2018, the DSMC monitored 58 studies, including the review of 120 progress reports, and 134 serious adverse events. Part III: Inclusion of Women and Minorities in Research. The HICCC maintains and supports multiple, proactive efforts to promote the recruitment of women and underrepresented minorities. In 2018, among the 710 individuals enrolled onto interventional studies, 64% were women and 48% represented ethnic and racial underrepresented minorities. Part IV: Inclusion Across the Lifespan in Research. The HICCC supports the NIH policy on the inclusion across the lifespan in research. The HICCC is an active member of the NCTN Children’s Oncology Group (COG) and other pediatric clinical trial networks. The HICCC is also active in NCI Adolescent and Young Adult initiatives and is a leading participant in the NCI Early Onset Malignancy Initiative. Enrollment of children and older adults are not restricted as long as criteria for eligibility...