Data Coordinating Center for Type 1 Diabetes TrialNet

项目总结/摘要 该应用程序请求支持审判网的持续运作 协调中心（TNCC）在南佛罗里达大学。南方大学 自2008年10月以来，佛罗里达一直担任TrialNet的协调中心。的 TrialNet的主要目的是预防或延迟类型的初始发作和/或进展 1型糖尿病（T1 D），通过在高风险个体中保留产生胰岛素的β细胞 以及新近被诊断为T1 DM的患者。为了实现这一目标，TrialNet 设计和实施预防和干预性临床试验， 可能保留最近诊断的剩余胰岛素分泌的治疗 个体（新发病）。TNCC提供流行病学、生物统计学、业务 和行政专业知识和建议的临床中心，参考实验室 和NIDDK，包括以下任务：1）研究范围内的沟通， 采购和分发研究材料及相关活动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)实施管理、方法和成本评估程序- TNCC使用的程序的有效性;和7）定期会议。这 应用程序为通信、数据 TrialNet研究的收集、编辑、处理、分析和报告， 包括数据质量、方案遵守和数据保密性在内的操作，以及 规定协调提交样品的实施和程序 以及从参与临床和附属中心到TrialNet Central的数据 实验室和NIDDK储存库。

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.