Clinical Islet Transplantation: 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. During the initial funding period, 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 seven of the CIT clinical trial protocols. The Information Technology and Biostatistics teams at the DCC have created electronic database systems to fully support all of the statistical and data management requirements for the CIT trials and continue to work to improve and upgrade these systems. 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 Consortium. This proposal requests a three-year extension of funding so that the CTSDMC may continue its service to the Consortium during the final implementation and reporting phases of the CIT clinical trials. RELEVANCE (provided by the applicant): Type 1 Diabetes affects as many as 3 million Americans. Through collaboration, the Clinical Islet Transplantation Consortium works to develop clinical trials relevant to the improvement of health and strategies for treatments to improve the health and wealthfare of those with Type 1 Diabetes.