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.

项目摘要/摘要 南佛罗里达大学是唯一有资格开展这项有限竞赛活动的大学 RFA。RFA的目的是为数据协调中心(DCC)职能的继续提供资金 以支持Teddy受试者的后续行动，并启动第二个嵌套病例对照队列。计划继续进行 DCC支持Teddy主题后续行动的职能包括：1)支持研究的执行 Teddy研究参与者随访协议2)接收、管理和分析从以下来源获得的数据 泰迪临床中心在提交和分析的所有步骤中保护患者的机密性 数据和确保数据管理系统的技术完整性和安全性4)监测 坚持研究计划，进行现场访问，以监测记录保存的质量，来源 文件和数据录入的准确性以及监督数据质量控制5)提供统计 在整个研究过程中提供支持、专业知识和监督；与临床研究人员在 编写演示文稿以及主要和次要出版物；并在 外部评价委员会(EEC)或NIDDK的请求，提供研究范围内的沟通； 传播研究材料，如方案、操作手册、表格或其他研究文件， 以及网站的开发和维护7)为临床医生提供培训和技术援助 执行后续评估的中心；协助执行议定书；并在 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分包合同。通过分包合同，DCC还将提供 对临床中心的研究访问和程序的补偿，包括数据和生物样本 采购以及开展研究所需的其他必要服务9)提供行政和后勤 为泰迪研究小组提供支助服务，包括编写出版物和组织定期 研究小组和小组委员会的会议、研讨会和电话会议。它也将对此负责 为由以下机构召集的外部评价委员会编写报告和组织会议 NIDDK。10)确保将所有生物样本和数据转移到NIDDK指定的储存库。它是 负责通过准备有限的个人健康信息来支持和促进数据共享 以适用于数据共享的格式标识的数据集，以提交给安全的NIDDK数据存储库 在公布初步和其他研究结果后或在完成数据收集后12个月 主端点。启动第二个嵌套病例对照队列的计划将反映第一个病例对照队列 并将提供机会来生成各种不同数据类型的数据，跨越所有年龄的Teddy 研究人口。