Limited Competition: Continued Follow-up of Subjects and Initiation of a Second Case-control Cohort in The Environmental Determinants of Diabetes in The Young Study (TEDDY)

有限的竞争：在年轻研究中糖尿病的环境决定因素（TEDDY）中继续对受试者进行随访并启动第二个病例对照队列

• 批准号: 10398923
• 负责人: JEFFREY P KRISCHER
• 金额: $ 1532.04万
• 依托单位: UNIVERSITY OF SOUTH FLORIDA
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-28 至 2025-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10398923
• 关键词: Adherence; Age; Autoantibodies; Clinical Investigator; Cohort Analysis; Collaborations; Communication; Confidentiality of Patient Information; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Management Resources; Data Security; Data Set; Development; Diabetes Mellitus; Dietary Factors; Disease; Documentation; Educational workshop; Ensure; Evaluation; Florida; Funding; Goals; HLA Antigens; Health; Individual; Infectious Agent; Infectious Diseases Research; Insulin-Dependent Diabetes Mellitus; Laboratories; Literature; Maintenance; Manuals; Messenger RNA; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Paper; Participant; Pathogenesis; Performance; Periodicals; Predisposition; Preparation; Procedures; Protocols documentation; Psychosocial Factor; Publications; Qualifying; Quality Control; Reporting; Research; Research Personnel; Sampling; Schedule; Secure; Services; Site Visit; Source; Specific qualifier value; Training; Universities; Viral Markers; Visit; Work; case control; clinical center; cohort; data de-identification; data quality; data repository; data sharing; environmental agent; follow up assessment; follow-up; meetings; operation; prevent; primary endpoint; repository; study population; symposium; timeline; web site

Project Summary/Abstract The University of South Florida is uniquely qualified to conduct the activities specified in this limited competition RFA. The purpose of the RFA is to fund the continuation of the Data Coordinating Center's (DCC's) functions in support of TEDDY subject follow-up and to initiate a second nested case-control cohort. Plans to continue the DCC's functions in support of TEDDY subject follow-up include: 1) Supporting the execution of the study protocol for follow-up of TEDDY study participants 2) Receiving, managing, and analyzing data obtained from the TEDDY Clinical Centers 3) Protecting patient confidentiality at all steps in the submission and analysis of the data and ensuring the technical integrity and security of the data management systems 4) Monitoring of adherence to the research plan by conducting site visits to monitor the quality of record keeping, source documentation and the accuracy of data entry and for overseeing data quality control 5) Providing statistical support, expertise and oversight throughout the study; collaborating with the clinical investigators in the preparation of presentations and primary and secondary publications; and providing additional analyses at the request of the External Evaluation Committee (EEC) or the NIDDK 6) Providing study-wide communications, dissemination of study materials such as protocols, Manual of Operations, forms or other study documents, and development and maintenance of the web site 7) Providing training and technical assistance to the Clinical Centers in performance of the follow-up assessments; assisting in protocol implementation; and working in conjunction with the Clinical Centers and NIDDK staff to oversee all aspects of Clinical Center performance, including timeliness and quality of data and biosample submission 8) Procurement and administration of subcontracts for laboratory and repository services. Through subcontracts the DCC will also provide capitated reimbursements to the Clinical Centers for study visits and procedures, including data and biosample acquisition, and other necessary services for conduct of the study 9) Providing administrative and logistical support services for the TEDDY Study Group including preparation of publications, and organizing periodic meetings for the study group and subcommittees, workshops, and conference calls. It will also be responsible for preparing reports for and organizing meetings of an External Evaluation Committee (EEC) convened by NIDDK. 10) Ensuring the transfer of all biosamples and data to the NIDDK designated repositories. It is responsible for supporting and promoting data sharing by preparing a limited personal health information or de- identified data set in a format appropriate for data sharing for submission to a secure NIDDK data repository after publication of the primary and other study results or 12 months after completion of data collection for the primary endpoint. Plans to initiate a second nested case-control cohort will mirror the first case-control cohort and will afford the opportunity to generate data of a variety of different data types across all ages of the TEDDY study population.

项目概要/摘要 南佛罗里达大学拥有开展本次有限竞赛中指定活动的独特资格 射频消融。 RFA 的目的是资助数据协调中心 (DCC) 职能的延续 支持 TEDDY 受试者随访并启动第二个巢式病例对照队列。计划继续 DCC 支持 TEDDY 受试者随访的职能包括： 1) 支持研究的执行 TEDDY 研究参与者的后续协议 2) 接收、管理和分析从以下来源获得的数据 TEDDY 临床中心 3) 在提交和分析数据的所有步骤中保护患者的机密性 数据并确保数据管理系统的技术完整性和安全性 4) 监控 通过进行实地考察来监督记录保存的质量、来源，从而遵守研究计划 记录和数据输入的准确性以及监督数据质量控制 5) 提供统计数据 整个研究过程中的支持、专业知识和监督；与临床研究人员合作 准备演示文稿以及主要和次要出版物；并提供额外的分析 应外部评估委员会 (EEC) 或 NIDDK 的要求 6) 提供研究范围内的沟通， 传播研究材料，例如方案、操作手册、表格或其他研究文件， 网站的开发和维护 7) 为临床提供培训和技术援助 后续评估绩效中心；协助协议实施；并工作于 与临床中心和 NIDDK 工作人员一起监督临床中心绩效的各个方面， 包括数据和生物样本提交的及时性和质量 8) 采购和管理 实验室和储存库服务的分包合同。通过分包合同，DCC 还将提供按人头 报销临床中心的研究访问和程序，包括数据和生物样本 9) 提供行政和后勤服务 为 TEDDY 研究小组提供支持服务，包括准备出版物和定期组织 研究组和小组委员会的会议、研讨会和电话会议。也将承担责任 为外部评估委员会（EEC）准备报告并组织会议 尼德克。 10) 确保将所有生物样本和数据转移到 NIDDK 指定的存储库。这是 负责通过准备有限的个人健康信息或数据来支持和促进数据共享 确定的数据集采用适合数据共享的格式，以便提交到安全的 NIDDK 数据存储库 主要研究结果和其他研究结果发表后或完成数据收集后 12 个月 主要终点。启动第二个巢式病例对照队列的计划将与第一个病例对照队列类似 并将提供生成跨所有年龄段的 TEDDY 的各种不同数据类型的数据的机会 研究人群。