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，并为病毒标志物（抗体）的研究增加资金，包括 COVID-19和组学数据的综合分析。竞争将足以吸引申请 从合作者的能力进行可靠的测量病毒标志物，并使 TEDDY研究者可以利用这些数据进行协作和综合分析。所提出的数据 协调中心的活动包括：1）执行TEDDY研究随访的研究方案 根据研究操作手册中的时间表和程序， 与参与者入组的临床中心和NIDDK工作人员合作。2)接收， 管理和分析从临床中心获得的数据3）。监测研究依从性 通过进行现场访问来监控记录保存的质量、源文件和 数据输入和监督数据质量控制。指导委员会、小组委员会和外部 评价委员会会议和讲习班。提供统计支助、专门知识和监督 在整个研究中。5)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. 6)在TEDDY的运作中发挥关键作用，提供培训和技术 协助临床中心进行随访评估;协助方案 实施;并与临床中心和NIDDK工作人员合作，监督 临床中心绩效，包括数据和生物样本提交的及时性和质量。第七章） 实验室服务分包合同的采购和管理，包括： 抗原实验室;自身抗体实验室，mRNA实验室，传染病实验室，和 其他实验室如有需要。8)为TEDDY研究提供行政及后勤支援服务 包括编写出版物，为研究组组织定期会议， 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至NIDDK中心 根据NIDDK制定的时间轴，（10）与临床 以协作和互动的方式与各中心合作，并在指导委员会中任职。征求 病毒标志物研究和综合分析的外部合作者将遵循既定机制 征求和评估建议。DCC已经成功地为几个核心TEDDY实验室做到了这一点， 这将是第三次请求进行综合数据分析。