Trial to Reduce IDDM in the Genetically at Risk (TRIGR) Data Management Unit

描述（由申请人提供）：该提案旨在继续资助TRIGR（减少遗传风险中的IDDM试验）数据管理单元（DMU）。南佛罗里达大学的DMU成立于2002年，最初由青少年糖尿病研究基金会提供为期两年的启动资金。由于TRIGR项目本身是NIH资助的，DMU的继续也取决于获得NIH的资助。该项目的临床和管理部分包含在匹兹堡大学（Dorothy Becker，PI）和赫尔辛基大学（Hans Akerbloom，PI）的单独NIH申请中。这项申请是三项相互关联的建议的一部分。DMU建议继续在TRIGR中发挥积极作用，并将继续负责数据管理系统、研究监测（方案累积、依从性、不良事件和研究结局）、数据分析和报告。DMU提供了一个协调的临床数据管理系统，用于收集、存储和分析组成研究组的多个国际临床研究中心的数据。数据管理系统是一个安全的基于网络的系统，包括捕获和整合人口统计学、实验室和临床数据的能力。

DESCRIPTION (provided by applicant): 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.