Follow-up on Subjects, Integrative Data Analysis and Measurement of Viral Antibodies in The Environmental Determinants of Diabetes in The Young Study (TEDDY)

青年糖尿病环境决定因素研究（TEDDY）中的受试者跟踪、综合数据分析和病毒抗体测量

• 批准号: 10392400
• 负责人: JEFFREY P KRISCHER
• 金额: $ 999.99万
• 依托单位: UNIVERSITY OF SOUTH FLORIDA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-13 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10392400
• 关键词: Adherence; Antibodies; Architecture; Autoantibodies; Autoimmunity; Award; Big Data; Biological; Biological Markers; Celiac Disease; Characteristics; Clinical Investigator; 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; Enrollment; Ensure; Evaluation; Florida; Funding; Gene Expression; Goals; HLA Antigens; Health; Immune system; Immunologic Markers; Individual; Infectious Agent; Infectious Diseases Research; Informatics; Insulin-Dependent Diabetes Mellitus; Laboratories; Literature; Logistics; Maintenance; Manuals; Measurement; Messenger RNA; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Paper; Participant; Pathogenesis; Performance; Periodicity; Play; Preparation; Procedures; Protocols documentation; Psychosocial Factor; Publications; Quality Control; Reporting; Research; Research Personnel; Role; Sampling; Sampling Studies; Schedule; Secure; Services; Site Visit; Source; Specific qualifier value; Specimen; Statistical Data Interpretation; Study Subject; Time; TimeLine; Training; Universities; Viral; Viral Antibodies; Viral Markers; Visit; Work; clinical center; data de-identification; data quality; data repository; data sharing; data warehouse; diabetes risk; dietary; endocrine pancreas development; environmental agent; follow up assessment; follow-up; islet autoimmunity; meetings; metabolomics; microbiome; operation; prevent; primary endpoint; repository; 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 add funds for studies of viral markers (antibodies) and the integrative analysis of omics data. Competition will be sufficient to attract applications from collaborators with the capability to perform reliable measurements of viral markers, and to make the data available to TEDDY investigators for collaborative, integrative analyses. The proposed Data Coordinating Center activities include: 1) Executing the study protocol for follow-up of TEDDY study participants according to schedules and procedures contained in the study's Manual of Operations and in collaboration with the Clinical Centers at which participants are enrolled and with NIDDK staff. 2) Receiving, managing, and analyzing data obtained from the clinical centers 3). 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 also for overseeing data quality control. Steering Committee, subcommittee, and external evaluation committee meetings and workshops.4). Providing statistical support, expertise and oversight throughout the study. 5) 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. 6) Playing a key role in the operational conduct of TEDDY, 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. 7) Procurement and administration of subcontracts for laboratory services, including: central human leukocyte antigen laboratory; the autoantibody laboratories, the mRNA laboratories, infectious disease laboratories, and other laboratories as needed. 8) 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. 9) Transfer of all biosamples and data to the NIDDK central repositories according to a timeline developed with the NIDDK. and 10) Working closely with the Clinical Centers in a collaborative and interactive manner and serving on the Steering Committee. The solicitation of external collaborators for studies of viral markers and integrative analyses will follow established mechanisms for soliciting and evaluating proposals. The DCC has successfully done this for several core TEDDY labs and this would be the third solicitation for integrative data analysis.

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 支持Teddy主题的后续行动，并增加对病毒标志物(抗体)和 组学数据的综合分析。竞争将足以吸引以下合作伙伴的申请 能够对病毒标志物进行可靠的测量，并将数据提供给Teddy 调查人员进行协作、综合分析。拟议的数据协调中心活动包括： 1)根据时间表和Teddy研究参与者的随访，执行研究方案 程序包含在研究的操作手册中，并与临床中心合作，网址为 哪些参与者是注册的，以及NIDDK的工作人员。2)接收、管理和分析获得的数据 来自临床中心3)。通过进行现场访问来监测研究计划的遵守情况 记录保存、原始文件的质量和数据录入的准确性，以及监督 数据质量控制。指导委员会、小组委员会和外部评估委员会会议和 工作室。4)。在整个研究过程中提供统计支持、专门知识和监督。5)提供研究-- 广泛交流、传播研究材料，如议定书、操作手册、表格或 其他研究文件，以及网站的开发和维护。6)发挥关键作用 Teddy的业务行为，为#年的临床中心提供培训和技术援助 后续评估的执行情况；协助执行议定书；以及协同工作 与临床中心和NIDDK工作人员一起监督临床中心绩效的方方面面，包括 数据和生物样本提交的及时性和质量。7)分包合同的采购和管理 提供实验室服务，包括：人类白细胞抗原中央实验室、自身抗体实验室、 信使核糖核酸实验室、传染病实验室和其他所需实验室。8)提供 为泰迪研究小组提供行政和后勤支助服务，包括编写出版物， 为研究小组和小组委员会组织定期会议、讲习班和电话会议。9) 根据与NIDDK共同制定的时间表，将所有生物样本和数据转移到NIDDK中央储存库 NIDDK。和10)以协作和互动的方式与临床中心密切合作 在指导委员会任职。邀请外部合作者研究病毒标志物和 综合分析将遵循征求和评价提案的既定机制。DCC已经 成功地为几个核心Teddy实验室完成了这项工作，这将是第三次征集集成数据 分析。