Clinical Protocol and Data Management

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CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM) ABSTRACT The Clinical Protocol and Data Management (CPDM) of the University of Alabama at Birmingham (UAB) Comprehensive Cancer Center (CCC) is charged with maintaining the highest standards of clinical investigation that are aligned with all UAB, state and federal regulations, while assisting investigators in protocol development and maintaining efficient processes related to clinical investigations. The CPDM is responsible for the following significant functions: 1) Coordination, tracking, and reporting of all cancer clinical research activity undertaken at UAB, 2) Continuous improvement of the clinical trial activation process, 3) Ongoing education and training of clinicians and clinical research staff, 4) Clinical trial data quality monitoring, 5) Cancer clinical trial participant safety, and 6) Actively ensuring all sections of the population represented in the UAB CCC's catchment area have the opportunity to be represented in cancer clinical trials. CPDM adds value to the work of the UAB CCC members by providing support for protocol development as well as navigating the PRMS approval process, and assuring that there is knowledgeable and professional support for investigators at all stages of experience with the clinical trials process. The CPDM accomplishes this objective by providing centralized critical staff and infrastructure for all aspects of clinical research coordination and activation, as well as the efficient, and ethical conduct of open protocols. It provides the monitoring of the studies and all aspects of quality assurance. In addition, the CPDM provides a centralized database of protocol-specific data. This robust organization assures that all clinical trials have excellent support in protocol adherence, regulatory compliance, and recruitment (especially minority recruitment). Outstanding clinical trial support and quality of the CPDM are demonstrated by a number of objective measures described below; four FDA audits over the last 15 years (3 for high enrollment in FDA pivotal clinical trials and 1 for a gene therapy trial) resulted with no 483 forms being issued. Patient enrollment has increased over the last three years, especially to investigator-initiated and early phase clinical trials. The CPDM has taken steps to modify the staff and improve the infrastructure in response to the changes in UAB CCC research emphasis and faculty, and to the changing regulatory environment over the past five years: 1. The CPDM has relocated to the newly renovated Wallace Tumor Institute; 2. The CPDM has implemented OnCore®, a comprehensive clinical trials management system; 3. The CPDM has implemented the Clinical Trials Monitoring Committee (CTMC); this committee monitors in real time active clinical trials in the UAB CCC for patient safety; 4. The CPDM has incorporated specialized protocol management teams who have enhanced both investigator-coordinator interaction and accrual to trials in high-priority areas. In summary, the CPDM has expanded its capacity and aligned its focus with the changing needs of UAB CCC members. CPDM continues to provide excellent coordinating and monitoring support.