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: 10260891
• 负责人: JEFFREY P KRISCHER
• 金额: $ 112.48万
• 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: 2020-09-14 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10260891
• 关键词: Adherence; Antibodies; Architecture; Autoantibodies; Autoimmunity; Award; Big Data; Biological; Biological Markers; COVID-19; 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; Diet; 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 sharing; data warehouse; diabetes risk; endocrine pancreas development; environmental agent; follow up assessment; follow-up; meetings; metabolomics; microbiome; operation; pandemic disease; prevent; primary endpoint; repository; symposium; web site

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), including COVID-19 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.

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的目的是为数据协调中心（DCC）功能的延续提供资金 支持泰迪受试者随访并增加用于病毒标记（抗体）的资金，包括 COVID-19和OMICS数据的综合分析。竞争足以吸引申请 从具有可靠测量病毒标记的合作者，并使 泰迪调查人员可用于协作，集成分析的数据。提出的数据 协调中心活动包括：1）执行泰迪研究随访的研究协议 根据研究手册中包含的时间表和程序，参与者 与参与者入学的临床中心以及NIDDK员工的合作。 2）接收， 管理和分析从临床中心获得的数据3）。监测遵守研究 通过进行现场访问来监控记录保存，源文档和准确性的质量 数据输入以及海外数据质量控制。指导委员会，小组委员会和外部 评估委员会会议和讲习班4）。提供统计支持，专业知识和监督的提供者 在整个研究中。 5）提供整个学习沟通，研究材料的传播，例如 协议，手册，表格或其他研究文件以及开发和维护 网站。 6）在泰迪的运营中发挥关键作用，提供培训和技术 为临床中心提供后续评估的帮助；协助协议 执行;并与临床中心和NIDDK员工一起工作，以在海外 临床中心表现，包括数据的及时性和质量和生物样品提交。 7） 实验室服务的分包合同的采购和管理，包括：中央人类白细胞 抗原实验室；自身抗体实验室，mRNA实验室，传染病实验室以及 根据需要的其他实验室。 8）为泰迪研究提供行政和后勤支持服务 小组包括准备出版物，并为研究小组组织定期会议 小组委员会，研讨会和电话会议。 9）将所有生物样本和数据转移到NIDDK Central 根据与NIDDK开发的时间表的存储库。 10）与临床紧密合作 以协作和互动的方式中心，并在指导委员会中任职。征集 用于病毒标记和综合分析研究的外部合作者将遵循既定的机制 用于征求和评估建议。 DCC已成功地为多个核心泰迪实验室和 这将是综合数据分析的第三次招标。