Clinical Protocol and Data Management (CPDM) is the administrative home for all of the units that support clinical research at the Abramson Cancer Center (ACC), providing essential support for and monitoring of all clinical research conducted in the ACC regardless of the type of intervention or sponsor. The CPDM, in collaboration with ACC Leadership, creates, directs and enforces the operational standards (policies) and expectations for the conduct of all clinical research within the ACC. The CPDM scope is of necessity broad, encompassing development and updating of policies and procedures, education and training, supervision of data managers and research nurses, and oversight over all of the specialty clinical research units within our Center. The CPDM manages our centralized Clinical Trials Management System (CTMS), Velos, organizes and performs quality assurance and QC/monitoring of clinical trials across the center, and directly manages the complex, ongoing and recurring activities of our mandatory clinical research review committees. Key units supported by the CPDM are the Department of Compliance and Monitoring (DOCM), the Protocol Review and Monitoring System (PRMS, known as the Clinical Trials Scientific Review and Monitoring Committee [CTSRMC]), the Data and Safety Monitoring Committee (DSMC), and the Clinical Research Unit (CRU). While CPDM provides the administrative support for PRMS and DSMC, it is vital to note that these are, by design, distinct entities. PRMS is described elsewhere in this renewal. The inclusion of Women and Minorities in clinical trials is a central focus of ACC Leadership and clinical investigators as a component of our commitment to addressing the cancer burden in minority and underserved populations. During the current award period, the ACC implemented several initiatives aimed at reducing disparities in cancer incidence and mortality in minorities, including completion of quality improvement training to further increase the diversity of the patients on cancer clinical trials at ACC, establishment of additional key partnerships with community organizations to increase educational efforts and community outreach, creation of cancer screening navigation programs that increase patient engagement and improve access to and completion of cancer screening tests, and recruitment of a cadre of patient navigators for common diseases in our catchment area affecting minorities, including lung, colorectal and breast cancer, in order to assist patients from all backgrounds in getting into our health care system and using it effectively. Children with cancer have traditionally had a very high participation rate in clinical research studies with the field of pediatric oncology often at the forefront of cancer clinical research. The ACC Pediatric Oncology Program has played a central role locally and nationally in improving our understanding of the biology of childhood cancers through the collection and study of human tumor specimens, and in advancing our knowledge of optimal treatments by conducting clinical trials and playing a very notable leadership role in national pediatric cooperative group and clinical research consortia.
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