Data Coordinating Center for Artificial Pancreas Studies

人工胰腺研究数据协调中心

• 批准号: 9898583
• 负责人: ROY W. BECK
• 金额: $ 100万
• 依托单位: JAEB CENTER FOR HEALTH RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-20 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9898583
• 关键词: Accountability; Accounting; Adult; Adverse event; Algorithms; Artificial Pancreas; Child; Clinical; Clinical Trials; Collection; Complement; Contracts; Data; Data Coordinating Center; Data Quality; Development; Devices; Ensure; Environment; Fostering; Funding; Health; Industry; Information Technology; Institution; Institutional Review Boards; Instruction; Insulin-Dependent Diabetes Mellitus; Investigation; Leadership; Manuals; Monitor; Multi-Institutional Clinical Trial; National Institute of Diabetes and Digestive and Kidney Diseases; Outpatients; Procedures; Process; Reporting; Research; Research Personnel; Role; Safety; Site; Statistical Data Interpretation; System; Testing; Trust; Work; base; clinical research site; efficacy evaluation; experience; financial conflict of interest; human subject protection; operation; participant safety; quality assurance; randomized trial; response; success

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

项目摘要 根据RFA选择的数据协调中心（DCC）将协调多个 临床试验涉及评估人造胰腺（AP）的效率和安全性 成人或1型糖尿病儿童的系统。 DCC对于多中心临床至关重要 审判。当DCC协调的研究将涉及研究时，尤其如此 该项目可能是这种情况。 JAEB卫生研究中心（JCHR）在1型研究方面拥有18年的研究经验 糖尿病，包括在过去10年中的众多AP研究的协调 NIDDK，JDRF，Helmsley慈善信托基金和行业。 JCHR作为机构和主要人员 因为这个项目具有DCC所需的专业知识和丰富的经验 成功的项目。 JCHR的计算环境和标准操作程序（SOP） 为先前项目开发的文件，说明手册和材料将用于 促进该项目的发展和行为。 JCHR具有很大的核心 信息技术，质量保证，合同，IRB，会计和一般 支持其所有项目并完成工作人员努力的运营人员 分配给这个项目。 该项目的具体目的是为每个AP研究开发DCC 由NIDDK资助。 DCC的功能和职责是广泛的 研究策略第3节，将包括以下内容： •协调临床站点的努力 •许多行政职能 •确保每个试验都是为人类受试者安全的最大保护 和机密性，包括不良事件和设备问题的审查和报告 •通过远程和现场监控来确保数据质量 •为收集，管理和分析开发符合法规的流程 研究数据；设备问责制；监管报告；利益冲突 报告 •研究结果的传播