Clinical Protocol and Data Management/Clinical Trials Office (Core 015)

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Clinical Protocol and Data Management (CPDM) PROJECT SUMMARY The Clinical Protocol and Data Management component of the Dan L Duncan Cancer Center (DLDCC) 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 DLDCC. CTSU services are available to all members of the DLDCC 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), maintenance of regulatory files, 2) Clinical trials informatics expertise, especially 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 especially for less experienced investigators. In the most recent year 07/01/2013 – 06/30/2014 the CTSU supported 170 interventional trials including 59 investigator- initiated studies, 31 of which are conducted under IND and three 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 DLDCC patient safety officer ensures that all data monitoring for Cancer Center trials is conducted in accordance with the approved monitoring plan. Relevance The Clinical Protocol and Data Management component of the Dan L Duncan Cancer Center is committed to providing an effective and efficient infrastructure to support the clinical research efforts of the Center.