Continuation of Clin Islet Transplantation Consortium: Data Coordinating Center

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DESCRIPTION (provided by applicant): This application proposes that the Clinical Trials Statistical and Data Management Center (CTSDMC) at The University of Iowa continue as the Data Coordinating Center (DCC) for the Clinical Islet Transplantation (CIT) Consortium. The DCC has served the CIT Consortium since its inception in 2004. Enrollment and initial transplants have been completed on all North American Islet Alone protocols. Recruitment continues in the Islet After Kidney protocol and the Nordic Group Protocol. During the previous funding periods, the DCC provided comprehensive services in the areas of project design and implementation, information technology, data monitoring, data management, statistical analysis, project coordination, regulatory control, quality assurance, and administration for all eight of th CIT clinical trial protocols. The Information Technology and Biostatistics teams created and continue to support electronic database systems for data acquisition, data quality control, and data analysis for the CIT trials. The DCC has also developed effective electronic systems for the collection, monitoring, and submission of regulatory documents. Our certified Protocol Coordinators collaborate closely with the investigators and staff at the clinical sites and the NIH to ensure that the Consortium's studies are provided with excellent logistical, administrative, and technical support. This proposal describes our progress, and provides evidence that the CTSDMC is uniquely qualified to continue as the Data Coordinating Center for the Clinical Islet Transplantation Consortium. This proposal requests a five-year extension of funding so that the CTSDMC may support the completion and reporting phases of the CIT clinical trials.