This proposal seeks to continue funding for the TRIGR (Trial to Reduce IDDM in the Genetically at Risk) Data Management Unit (DMU). Established in 2002, the DMU at the University of South Florida was initially funded by a two-year start-up grant from the Juvenile Diabetes Research Foundation. As the TRIGR project itself is NIH funded, continuation of the DMU is dependent upon obtaining NIH funding as well. The clinical and administrative parts of the project are contained in separate NIH applications from the University of Pittsburgh (Dorothy Becker, PI) and the University of Helsinki (Hans Akerbloom, PI). This application is one part of the three interlocking proposals. The DMU proposes to continue to play an active role in TRIGR and will continue to have responsibility for data management systems, study monitoring (protocol accrual, compliance, adverse events, and study outcomes), data analysis and reporting. The DMU provides a coordinated clinical data management system for the collection, storage and analysis of data from the multiple international clinical sites that comprise the study group. The data management system is a secure web based system that includes the capability to capture and integrate demographic, laboratory and clinical data. ? ? ?
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