? CLINICAL PROTOCOL AND DATA MANAGEMENT The DCI Clinical Protocol Data Management (CPDM) team resides in the Clinical Research Office (CRO) and provides comprehensive protocol and data management services to DCI members including development, conduct, data management, monitoring and reporting of cancer-related clinical research. The CPDM mission is to provide the infrastructure for centralized processes that allow the facilitation, assessment of the scientific merit, progress, QA, safety and reporting of all cancer-related clinical protocols to support the DCI?s mission of providing novel and innovative therapies to all of our patients affected by cancer. The CPDM provides comprehensive clinical research protocol services to DCI members from concept development, regulatory submission, data reporting, protocol monitoring, and close out. This centralized approach allows the CRO to proactively assess the clinical trials portfolio, its performance, compliance with regulatory standards, and its alignment with DCI and institutional priorities. The DCI CRO provides comprehensive data and metrics to the DCI leadership, multidisciplinary Disease Groups, Research Program leaders, and investigators to support their operations and decisions. The CPDM enables the Protocol Review and Monitoring System (PRMS) to analyze protocol startup and approval times in order to identify gaps in review process to provide ongoing efficiency. CPDM also permits the DCI to comply with federally mandated ClinicalTrials.gov and NCI Clinical Trials Reporting Program (CTRP) requirements. The CPDM facilitates design and development of clinical trial databases in a 21CFR Part 11 compliant electronic data capture platforms. During the past project period, the CPDM expanded the use of technology to facilitate efficacy and efficiency. With the School of Medicine, DCI implemented an electronic regulatory platform (Complion), Clinical Trials Management System (OnCore), a new eIRB system (iRIS) and a DCI membership console to collect shared resource utilization by research program and track member publications. The CPDM?s overarching goal is to ensure access to clinical trials for all of our patients. Special efforts are undertaken to provide the opportunity for patients to participate in clinical trials regardless of sex/gender, race, ethnicity, socioeconomic status, or age. During the current 5 year grant period, the DCI enrolled 13,826 subjects on clinical research protocols, including 7,413 subjects to interventional trials and 540 pediatric subjects. Enrolled subjects based on total accrual included 7,919 (57.3%) females and 2,954 (21%) minorities. There is also a substantial commitment to support of National Clinical Trials Network (NCTN) and UM1/ETCTN studies, with 358 patients accrued to adult NCTN treatment studies, 319 enrolled to NCORP studies, 279 enrolled to pediatric COG studies and 102 patients accrued to UM1/ETCTN studies over the past 5 years.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Center Core Grants (P30)
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Subcommittee I - Transistion to Independence (NCI)
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Duke University
United States
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