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: 10227415
• 负责人: JEFFREY P KRISCHER
• 金额: $ 2837.88万
• 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/10227415
• 关键词: Adherence; Age; Autoantibodies; Clinical Investigator; Cohort Analysis; 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; Logistics; Maintenance; Manuals; Messenger RNA; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Paper; Participant; Pathogenesis; Performance; Periodicity; Preparation; Procedures; Protocols documentation; Psychosocial Factor; Publications; Quality Control; Reporting; Research; Research Personnel; Sampling; Schedule; Secure; Services; Site Visit; Source; Specific qualifier value; Study Subject; Time; TimeLine; 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; 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.

项目摘要/摘要 南佛罗里达大学具有独特的资格，可以在这项有限的比赛中进行指定的活动 RFA。 RFA的目的是资助数据协调中心（DCC）功能的延续 支持泰迪受试者随访并启动第二个嵌套的病例对照队列。计划继续 DCC支持泰迪主题后续行动的功能包括：1）支持研究的执行 泰迪研究参与者的后续行动2）接收，管理和分析从 泰迪临床中心3）在提交和分析的所有步骤中保护患者机密性 数据并确保数据管理系统的技术完整性和安全性4）监视 通过进行现场访问来监视记录保存的质量，来遵守研究计划 文档和数据输入的准确性和监督数据质量控制5）提供统计 在整个研究中的支持，专业知识和监督；与临床研究人员合作 准备演讲以及主要和次要出版物；并在 外部评估委员会（EEC）或NIDDK的要求6）提供全面的沟通， 传播研究材料，例如协议，操作手册，形式或其他研究文件， 以及网站的开发和维护7）为临床提供培训和技术帮助 后续评估的表现中心；协助协议实施；并在工作 与临床中心和NIDDK员工共同监督临床中心表现的各个方面， 包括数据的及时性和质量以及生物样本提交8） 分包实验室和存储库服务的合同。通过分包合同，DCC还将提供倾销 向临床中心报销研究就诊和程序，包括数据和生物样本 收购以及其他进行研究的必要服务9）提供行政和后勤 泰迪研究小组的支持服务，包括准备出版物和定期组织 研究小组和小组委员会，研讨会和电话会议的会议。这也将负责 用于准备外部评估委员会（EEC）的报告和组织会议 niddk。 10）确保将所有生物样本和数据传输到NIDDK指定存储库。这是 负责通过准备有限的个人健康信息或de-来支持和促进数据共享 以适合数据共享的格式确定的数据集，用于提交给安全的NIDDK数据存储库 在发布主要研究结果和其他研究结果之后，或完成数据收集后的12个月后 主要终点。启动第二个嵌套案例对照队列的计划将镜像第一个案例对照队列 并将有机会在泰迪（Teddy）的所有年龄段生成各种不同数据类型的数据 研究人群。