Data Coordinating Center for Type 1 Diabetes TrialNet

项目摘要/摘要 该应用程序请求为TrialNet的持续运营提供支持 南佛罗里达大学协调中心(TNCC)。南方大学 自2008年10月以来，佛罗里达州一直是TrialNet的协调中心。这个 TrialNet的主要目标是预防或延迟初发和/或进展的类型 1糖尿病(T1D)，通过保存高风险个体中产生胰岛素的β细胞 以及那些新诊断为T1 DM的人。为了实现这一目标，TrialNet 设计和实施预防和干预临床试验，旨在测试 新近确诊的患者可能保留剩余胰岛素分泌的治疗 个人(新开始)。TNCC提供流行病学、生物统计学、可操作性 以及对临床中心、参考实验室的管理专业知识和建议 和NIDDK，包括以下任务：1)学习范围内的沟通， 采购和传播研究材料及相关活动2)数据 管理和记录维护；3)临床站点和中心实验室 监测；4)数据分析；5)编写研究报告和论文以供出版； 6)实施评估管理、方法和成本的程序- 技术协调委员会采用的程序的有效性；以及7)定期会议。这 应用程序为通信、数据的增强和升级提供支持 TrialNet研究和报告的收集、编辑、处理、分析和报告 包括数据质量、协议遵守和数据机密性在内的操作，以及 规定协调提交样品的实施和程序 和从参与的临床和附属中心到TrialNet中心的数据 实验室和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 (T1D) 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 application provides support for 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 procedures for coordinating submission of samples and data from the participating Clinical and Affiliate Centers to the TrialNet Central Laboratories and NIDDK Repository.