Continuation of Clin Islet Transplantation Consortium: 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。所有北美单独胰岛方案的入组和初始移植均已完成。在肾后胰岛方案和北欧组方案中继续招募。在以往的资助期内，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、质量保证和所有八项CIT临床试验方案的行政管理等方面提供了全面的服务。信息技术和生物统计学团队创建并继续支持电子数据库系统，用于CIT试验的数据采集、数据质量控制和数据分析。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 确保为联合体的研究提供良好的后勤、行政和 技术支持.该提案描述了我们的进展，并提供了CTSDMC唯一有资格继续作为临床胰岛移植联盟数据协调中心的证据。该提案要求将资金延长五年，以便CTSDMC可以支持CIT临床试验的完成和报告阶段。

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. Enrollment and initial transplants have been completed on all North American Islet Alone protocols. Recruitment continues in the Islet After Kidney protocol and the Nordic Group Protocol. During the previous funding periods, 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 eight of th CIT clinical trial protocols. The Information Technology and Biostatistics teams created and continue to support electronic database systems for data acquisition, data quality control, and data analysis for the CIT trials. 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 Clinical Islet Transplantation Consortium. This proposal requests a five-year extension of funding so that the CTSDMC may support the completion and reporting phases of the CIT clinical trials.