Clinical, Protocol and Data Management

点击翻译按钮获取中文摘要

CPDM PROJECT SUMMARY The Clinical Protocol and Data Management component of the Dan L Duncan Comprehensive Cancer Center (DLDCCC) includes the Clinical Trials Support Unit (CTSU) and the Data Review and Safety Monitoring Committees. The CTSU provides central management, research support, and oversight functions for the conduct of cancer-related clinical trials at all ambulatory care centers and hospitals that are part of the DLDCCC. CTSU services are available to all members of the DLDCCC engaged in clinical research. The major functions of the CTSU are to provide: 1. Assistance with regulatory and administrative matters relating to clinical research and trials, including IRB compliance and approval, ongoing amendments and renewal, external agency compliance (such as the FDA), and maintenance of regulatory files, 2. Clinical trials informatics expertise, in particular maintaining an electronic database of cancer-related clinical protocols, patient registry and clinical data, and monitoring and reporting on accrual, 3. Quality Assurance/Quality Control auditing and personnel training to ensure that the research team is trained in best practices in clinical research, and 4. Research nursing/clinical trials management. In the most recent year 01/01/2018–12/31/2018, the CTSU supported 224 interventional trials including 54 investigator-initiated studies, 30 of which are conducted under IND and 3 under an IDE. The Data Review and Safety Monitoring Committees are separate from the operational aspect of clinical trials managed by the CTSU and function to ensure the safety of participants, the validity of data, and the appropriate termination of studies in the event that undue risks have been uncovered, or it appears that trials cannot be conducted successfully. The DLDCCC patient safety officer ensures that all data monitoring for Cancer Center trials is conducted in accordance with the approved monitoring plan. The CPDM also monitors accrual to ensure there is appropriate representation of women, minorities, children, and older adults in clinical research.