Data Coordinating Center for Type 1 Diabetes TrialNet (UC4)USF: TrialNet UC4-3

1 型糖尿病数据协调中心 TrialNet (UC4)USF：TrialNet UC4-3

• 批准号: 9506924
• 负责人: JEFFREY P KRISCHER
• 金额: $ 4264.62万
• 依托单位: UNIVERSITY OF SOUTH FLORIDA
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-22 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9506924
• 关键词: Address; Adherence; Award; Beta Cell; Biological; Biological Markers; Biometry; Characteristics; Clinical; Clinical Trials; Committee Members; Communication; Conduct Clinical Trials; Contracts; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Quality; Development; Diabetes Mellitus; Diabetes prevention; Diagnosis; Disease; Enrollment; Ensure; Epidemiology; Florida; Funding; Future; Goals; Grant; Individual; Insulin; Insulin-Dependent Diabetes Mellitus; Intervention; Intervention Studies; Investigation; Laboratories; Lead; Maintenance; Manuals; Methodology; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Newly Diagnosed; Paper; Pathogenesis; Periodicity; Population; Preparation; Prevention; Preventive Intervention; Procedures; Process; Protocols documentation; Publications; Quality Control; Questionnaires; Records; Recruitment Activity; Reporting; Request for Applications; Research; Risk; Risk Assessment; Risk Factors; Safety; Sampling; Site; Specimen; Statistical Data Interpretation; System; Testing; Universities; Update; clinical research site; cost effectiveness; data management; design; diabetes risk; follow-up; innovation; insight; insulin dependent diabetes mellitus onset; insulin secretion; meetings; novel strategies; novel therapeutics; operation; prevent; protocol development; repository; research study; responders and non-responders; response; symposium; trial design

Project Summary/Abstract This application requests support for the continuing operations of the TrialNet Coordinating Center (TNCC) at the University of South Florida. The University of South Florida has served as the Coordinating Center for TrialNet since October, 2008. The primary objective of TrialNet is to prevent or delay initial onset and/or progression of type 1 diabetes (T1DM) by preserving insulin-producing beta cells in individuals at elevated risk and those who have been newly diagnosed with T1DM. To achieve this goal, TrialNet designs and implements prevention and interventional clinical trials intended to test treatments that may preserve remaining insulin secretion in recently diagnosed individuals (new-onsets). The TNCC provides epidemiological, biostatistical, operational and administrative expertise and advice to the clinical centers, reference laboratories and the NIDDK which include the following tasks: 1) study-wide communications, procurement and dissemination of study materials, and related activities 2) data management and records maintenance; 3) clinical site and central laboratories monitoring; 4) data analyses; 5) preparation of study reports and papers for publication; 6) implementation of procedures to evaluate management, methodology, and cost-effectiveness of procedures utilized by the TNCC; and 7) periodic meetings. This new application provides additional support to focus on the design and conduct of new-onset trials (as selected by the TrialNet Steering Committee) and associated mechanistic studies that can lead to targeted trials to prevent or delay progression of T1D, provide enhancements and upgrades for communication, data collection, editing, processing, analysis, and reporting for TrialNet studies and operations including data quality, protocol adherence and data confidentiality, and provide for implementation and upgrading of procedures for coordinating submission of samples and data from the participating Clinical and Affiliate Centers to the TrialNet Central Laboratories and NIDDK Repository.

项目总结/摘要 该应用程序请求支持审判网协调中心的持续运作。 中心（TNCC）在南佛罗里达大学。南佛罗里达大学曾担任 自2008年10月以来，审判网协调中心。TrialNet的主要目标是 预防或延迟1型糖尿病（T1 DM）的初始发作和/或进展， 胰岛素分泌β细胞在高风险个体和那些谁是新的 诊断为T1 DM。为了实现这一目标，TrialNet设计并实施了预防和 干预性临床试验，旨在测试可能保留剩余胰岛素的治疗 最近诊断的个体（新发）分泌。TNCC提供流行病学， 生物统计学、操作和管理专业知识以及对临床中心的建议， 参考实验室和NIDDK，包括以下任务：1）研究范围 交流、采购和分发学习材料以及相关活动2） 数据管理和记录维护; 3）临床研究中心和中心实验室监测; 4)数据分析; 5）编写研究报告和论文供出版; 6）执行 评价程序的管理、方法和成本效益的程序 由TNCC使用;和7）定期会议。此新应用程序提供了额外的支持 专注于设计和开展新的试验（由TrialNet指导委员会选定） 委员会）和相关的机制研究，可以导致有针对性的试验，以防止或 延迟T1 D的进展，提供通信、数据 为TrialNet研究和运行收集、编辑、处理、分析和报告 包括数据质量、方案依从性和数据保密性，并规定 执行和改进协调提交样品的程序， 从参与临床和附属中心到TrialNet中心实验室的数据 NIDDK Repository。