Data Coordinating Center for Artificial Pancreas Studies

人工胰腺研究数据协调中心

• 批准号: 10187193
• 负责人: ROY W. BECK
• 金额: $ 29.64万
• 依托单位: JAEB CENTER FOR HEALTH RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-30 至 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10187193
• 关键词: Accountability; Accounting; Adult; Adverse event; Algorithms; Artificial Pancreas; Child; Clinical; Clinical Trials; Collection; Complement; Contracts; Data; Data Coordinating Center; 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; data quality; 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 评价人工胰腺（AP）有效性和安全性的临床试验 1型糖尿病患者的饮食习惯DCC对于多中心临床研究至关重要。 审判当DCC协调的研究涉及研究性研究时， 设备，就像这个项目可能会出现的情况一样。 Jaeb健康研究中心（Jaeb Center for Health Research）在1型糖尿病研究方面有18年的经验， 糖尿病，包括在过去10年中资助的许多AP研究的协调， NIDDK，JDRF，Helmsley慈善信托基金和工业。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经验，以确保 成功的项目。Java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、指导手册和材料， 促进该项目的开发和实施。Jesus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 支持所有项目并补充工作人员工作的运营人员 分配到这个项目。 本项目的具体目标是为每项AP研究单独开发DCC 由NIDDK资助。发展协调委员会的职能和职责广泛，如 研究战略第3节将包括以下内容： ·协调临床研究中心的工作 ·许多行政职能 ·确保每项试验的进行都能最大限度地保护人类受试者的安全 和保密性，包括审查和报告不良事件和器械问题 ·通过远程和现场监控确保数据质量 ·制定符合法规的收集、管理和分析流程 研究数据;器械清点;监管报告;经济利益冲突 报告 ·传播研究成果