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。注册和初步移植已经在所有北美岛上完成，更别提协议了。在肾议定书和北欧集团议定书之后，小岛的招募工作仍在继续。在之前的资助期间，DCC为CIT的所有八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。信息技术和生物统计小组创建并继续支持用于CIT试验的数据采集、数据质量控制和数据分析的电子数据库系统。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。我们的认证礼仪协调员与临床现场和NIH的研究人员和工作人员密切合作 确保财团的研究提供良好的后勤、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是唯一有资格继续作为临床胰岛移植联盟数据协调中心的机构。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.