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

基本信息

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
项目类别：
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

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

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项目摘要

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.

项目摘要/摘要该申请要求支持试用网协调的持续操作南佛罗里达大学的中心（TNCC）。南佛罗里达大学曾担任自2008年10月以来，试验网的协调中心。试验网的主要目标是通过保留1型糖尿病（T1DM）的初始发作和/或进展风险升高的个体中产生胰岛素的β细胞和那些新的人被诊断为T1DM。为了实现这一目标，试验网设计和实施预防和实施介入的临床试验旨在测试可能保留剩余胰岛素的治疗最近被诊断的个体（新诊断）的分泌。 TNCC提供流行病学，为临床中心的生物统计，运营和行政专业知识和建议，参考实验室和NIDDK，其中包括以下任务：1）在整个学习范围内研究材料的沟通，采购和传播以及相关活动2）数据管理和记录维护； 3）临床部位和中央实验室监测； 4）数据分析； 5）准备研究报告和发表论文； 6）实施评估程序的管理，方法和成本效益的程序由TNCC使用； 7）定期会议。该新应用程序提供了额外的支持专注于新发行试验的设计和行为（根据试用网的选择委员会）和相关的机械研究，可以导致针对性的试验以防止或延迟T1D的进展，提供通信的增强和升级，数据试验网和操作的收集，编辑，处理，分析和报告包括数据质量，协议依从性和数据机密性，并提供实施和升级程序，以协调样本的提交和来自参与的临床和会员中心到试验网中心实验室的数据和NIDDK存储库。