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.

项目总结/摘要 南佛罗里达大学是唯一有资格进行在这个有限的竞争指定的活动 射频消融RFA的目的是为数据协调中心（DCC）继续履行职能提供资金 支持TEDDY受试者随访，并启动第二个嵌套病例对照队列。计划继续 DCC在支持TEDDY受试者随访方面的职能包括：1）支持研究的执行 TEDDY研究参与者的随访方案2）接收、管理和分析从以下方面获得的数据： TEDDY临床中心3）在提交和分析的所有步骤中保护患者机密性 数据和确保数据管理系统的技术完整性和安全性4）监测 遵守研究计划，进行现场访问，以监测记录保存的质量， 记录和数据输入的准确性，并监督数据质量控制5）提供统计 在整个研究过程中提供支持、专业知识和监督;与临床研究者合作， 编写报告和主要及次要出版物;并在 外部评价委员会（EEC）或NIDDK的要求6）提供研究范围内的通信， 分发研究材料，如方案、操作手册、表格或其他研究文件， 7）为临床研究提供培训和技术援助， 各中心开展后续评估;协助方案执行;以及 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， 包括数据和生物样品提交的及时性和质量 实验室和存放处服务的分包合同。通过分包合同，DCC还将提供 向临床中心报销研究访视和程序费用，包括数据和生物样本 采购以及进行研究所需的其他必要服务9）提供行政和后勤服务 为TEDDY研究小组提供支持服务，包括编写出版物和组织定期 研究小组和小组委员会会议、讲习班和电话会议。又负责 为外部评估委员会（EEC）编写报告并组织会议， NIDDK。10)确保将所有生物样本和数据转移到NIDDK指定的储存库。是 负责支持和促进数据共享，准备有限的个人健康信息或数据， 以适合于数据共享的格式识别数据集，以提交给安全的NIDDK数据存储库 主要研究结果和其他研究结果发表后或数据收集完成后12个月， 主要终点。计划启动第二个巢式病例对照队列将反映第一个病例对照队列 并将提供机会，以产生各种不同的数据类型的数据，在所有年龄的TEDDY 研究人群。