Clinical Islet Transplantation: Data Coordinating Center

描述(由申请人提供)： 这项申请建议爱荷华大学的临床试验统计和数据管理中心(CTSDMC)继续作为临床胰岛移植(CIT)联盟的数据协调中心(DCC)。DCC自CIT财团2004年成立以来一直为其提供服务。在最初的资助期间，DCC为CIT的所有七个临床试验方案提供了项目设计和实施、信息技术、数据监测、数据管理、统计分析、项目协调、监管控制、质量保证和管理等领域的全面服务。DCC的信息技术和生物统计小组已经创建了电子数据库系统，以完全支持CIT试验的所有统计和数据管理要求，并继续努力改进和提升这些系统。DCC还开发了有效的电子系统，用于收集、监测和提交管理文件。我们的认证方案协调员与临床现场和NIH的研究人员和工作人员密切合作，确保联盟的研究获得出色的后勤、行政和技术支持。这份提案描述了我们的进展，并提供了证据，证明CTSDMC是唯一有资格继续担任财团数据协调中心的机构。该提案要求将资金延长三年，以便CTSDMC可以在CIT临床试验的最后实施和报告阶段继续为该联盟提供服务。 相关性(由申请人提供)：1型糖尿病影响多达300万美国人。通过合作，临床胰岛移植联盟致力于开发与改善健康相关的临床试验，以及改善1型糖尿病患者健康和财富的治疗策略。

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.