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

项目摘要/摘要 该应用程序请求为TrialNet协调的持续运作提供支持 南佛罗里达大学(TNCC)的研究中心。南佛罗里达大学一直担任 自2008年10月以来一直是TrialNet的协调中心。TrialNet的主要目标是 预防或延缓1型糖尿病(T1 DM)的初始发病和/或进展 高危人群和新近出生的人群中产生胰岛素的β细胞 诊断为T1 DM。为了实现这一目标，TrialNet设计并实施了预防和 旨在测试可能保留剩余胰岛素的治疗方法的介入性临床试验 新近确诊的个体的分泌物(新发病病例)。TNCC提供了流行病学、 向临床中心提供生物统计、操作和管理方面的专门知识和建议， 参考实验室和NIDDK，包括以下任务：1)研究范围 传播、采购和传播学习材料及相关活动2) 数据管理和记录维护；3)临床现场和中心实验室监测； 4)数据分析；5)编写研究报告和论文以供出版；6)执行 评估程序的管理、方法和成本效益的程序 被技术合作委员会利用；以及7)定期会议。这一新应用程序提供了额外的支持 专注于设计和实施新的试验(由TrialNet指导选择 委员会)和相关的机制研究，可导致有针对性的试验，以防止或 延迟T1D进度，为通信、数据提供增强和升级 TrialNet研究和运营的收集、编辑、处理、分析和报告 包括数据质量、遵守协议和数据机密性，并规定 实施和改进协调提交样本和 从参与的临床中心和附属中心到TrialNet中心实验室的数据 和NIDDK存储库。

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.