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.

南佛罗里达大学拥有开展本次有限竞赛中指定活动的独特资格 RFA 的目的是资助数据协调中心 (DCC) 职能的延续。 支持 TEDDY 受试者后续行动，并为病毒标记物（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应用。 来自有能力对病毒标记物进行可靠测量的合作者，并做出 可供 TEDDY 研究人员进行协作、综合分析的数据。 协调中心的活动包括： 1) 执行 TEDDY 研究后续研究方案 参与者根据研究操作手册和中包含的时间表和程序 与参加者注册的临床中心以及 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). 通过进行现场访问来监控记录保存的质量、源文件和准确性来制定计划 数据输入以及监督数据质量控制。 评估委员会会议和研讨会。4).提供统计支持、专业知识和监督 5) 在整个研究过程中提供研究交流、传播研究材料，例如 协议、操作手册、表格或其他研究文件，以及开发和维护 6) 在 TEDDY 的运营行为中发挥关键作用，提供培训和技术。 协助临床中心进行后续评估，协助制定方案； 实施；并与临床中心和 NIDDK 工作人员合作监督各个方面 临床中心绩效，包括数据和生物样本提交的及时性和质量7)。 实验室服务分包合同的采购和管理，包括：人类中心白细胞 抗原实验室；自身抗体实验室、mRNA实验室、传染病实验室，以及 8）为TEDDY研究提供行政和后勤支持服务。 小组包括准备出版物、组织研究组定期会议和 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 中央。 根据与 NIDDK 制定的时间表建立存储库，以及 10) 与临床部门密切合作。 以协作和互动的方式建立中心并在指导委员会中任职。 病毒标记物研究和综合分析的外部合作者将遵循既定机制 DCC 已成功为多个核心 TEDDY 实验室和项目进行了征集和评估。 这将是第三次综合数据分析招标。