Clinical Islet Transplantation: Data Coordinating Center

描述（由申请人提供）： 本申请建议爱荷华州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2004年成立以来一直为CIT财团服务。在最初的资助期间，DCC在项目设计和实施、信息技术、数据监测、数据管理、统计分析、项目协调、监管控制、质量保证和所有七项CIT临床试验方案的行政管理等领域提供全面服务。DCC的信息技术和生物统计团队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，并继续努力改进和升级这些系统。发展协调委员会还开发了有效的电子系统，用于收集、监测和提交监管文件。我们的认证方案协调员与临床研究中心和NIH的研究人员和工作人员密切合作，以确保为联盟的研究提供出色的后勤，行政和技术支持。该提案描述了我们的进展，并提供了CTSDMC有唯一资格继续作为联盟数据协调中心的证据。该提案要求将资金延长三年，以便CTSDMC在CIT临床试验的最终实施和报告阶段继续为联盟提供服务。 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和治疗策略相关的临床试验，以改善1型糖尿病患者的健康和财富。

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.