Data Coordinating Center for Artificial Pancreas Studies

项目摘要 响应RFA而选择的数据协调中心(DCC)将协调多个 评价人工胰腺(AP)有效性和安全性的临床试验 适用于患有1型糖尿病的成人或儿童的系统。DCC对于多中心临床来说是必不可少的 审判。当DCC协调的研究将涉及调查时，情况尤其如此 设备，很可能就是这个项目的情况。 Jaeb健康研究中心(JCHR)在1型研究方面有18年的经验 糖尿病，包括协调过去10年的许多AP研究，由 NIDDK、JDRF、赫尔姆斯利慈善信托基金和行业。JCHR作为一个机构和主要工作人员 对于这个项目，拥有DCC所需的专业知识和丰富的经验，以确保 成功的项目。JCHR的计算环境和标准操作程序(SOP) 将利用为先前项目开发的文件、说明手册和材料 促进该项目的开发和实施。JCHR有一个实质性的核心 信息技术、质量保证、合同、IRB、会计和一般 支持其所有项目并补充工作人员努力的运营人员 分配给此项目。 该项目的具体目标将是为每个AP研究单独开发一个DCC 由NIDDK提供资金。DCC的职能和职责广泛，如中所述 研究战略第3部分，将包括以下内容： ·协调临床站点的工作 ·许多行政职能 ·确保在最大限度保护受试者安全的情况下进行每一次试验 和保密性，包括审查和报告不良事件和设备问题 ·通过远程和现场监控确保数据质量 ·为收集、管理和分析制定符合法规的流程 研究数据；设备责任；监管报告；财务利益冲突 报告 ·传播研究成果

Project Summary The Data Coordinating Center (DCC) selected in response to the RFA will coordinate multiple clinical trials involving the evaluation of the efficacy and safety of artificial pancreas (AP) systems for adults or children with type 1 diabetes. A DCC is essential for a multi-center clinical trial. This is especially true when the studies coordinated by the DCC will involve investigational devices as will likely be the case for this project. The Jaeb Center for Health Research (JCHR) has 18 years’ experience with studies in type 1 diabetes, including the coordination of numerous AP studies over the last 10 years funded by NIDDK, JDRF, Helmsley Charitable Trust, and industry. JCHR as an institution and the key staff for this project have the expertise and extensive experience needed for the DCC to ensure a successful project. JCHR’s computing environment, and Standard Operating Procedure (SOP) documents, instruction manuals, and materials developed for prior projects will be utilized to facilitate the development and conduct of this project. JCHR has a substantial core of Informational Technology, Quality Assurance, Contracts, IRB, Accounting, and General Operations staff who support all of its projects and complement the effort of the staff who are assigned to this project. The specific aim for this project will be development of a DCC for each AP study separately funded by NIDDK. The functions and responsibilities of the DCC are extensive as described in Research Strategy section 3 and will include the following: • coordinating the efforts of the clinical sites • many administrative functions • assuring that each trial is conducted with maximum protection for human subjects’ safety and confidentiality, including review and reporting of adverse events and device issues • assuring data quality through both remote and on-site monitoring • developing regulatory-compliant processes for the collection, management, and analysis of study data; device accountability; regulatory reporting; financial conflict of interest reporting • dissemination of study results