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

在遗传风险 (TRIGR) 数据管理单元中进行减少 IDDM 的试验

• 批准号: 7468071
• 负责人: JEFFREY P KRISCHER
• 金额: $ 55.52万
• 依托单位: UNIVERSITY OF SOUTH FLORIDA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-07-10 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7468071
• 关键词: Adverse event; Clinical; Clinical Data; Collection; Data Analyses; Florida; Foundations; Funding; Grant; Insulin-Dependent Diabetes Mellitus; International; Laboratories; Monitor; Online Systems; Outcome Study; Play; Protocols documentation; Reporting; Research; Risk; Role; Secure; System; United States National Institutes of Health; Universities; clinical research site; data management

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.

描述(由申请人提供)：本提案寻求继续为TRIGR(减少遗传风险人群中IDDM的试验)数据管理单位(DMU)提供资金。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的为期两年的启动资金资助。由于TRIGR项目本身是由NIH资助的，DMU的持续也取决于获得NIH的资金。该项目的临床和管理部分包含在匹兹堡大学(多萝西·贝克尔，PI)和赫尔辛基大学(汉斯·阿克布卢姆，PI)分别提交的NIH申请中。这项申请是三项连锁提案的一部分。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(方案应计、遵从性、不良事件和研究结果)、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、存储和分析来自组成研究小组的多个国际临床站点的数据。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、实验室和临床数据的能力。