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.
The goal of The Environmental Determinants of Diabetes in the Young Study (TEDDY) is the identification of infectious agents, dietary factors, or other environmental agents, including psychosocial factors which trigger type 1 diabetes (T1D) in genetically susceptible individuals. This project will extend the study to include viral markers. Identification of such factors will lead to a better understanding of disease pathogenesis and result in new strategies to prevent, delay or reverse T1D. Also, the project will solicit applications for integrative analyses. The Coordinating Center maintains the study protocol and provides project oversight, coordination, communication, statistical analyses and capability to collect longitudinal data and results of laboratory analyses of biological specimens from individuals at risk for diabetes. The TEDDY study includes analyses of dietary biomarkers, metabolomics, gene expression and the microbiome in assessing characteristics of those developing autoimmunity, Type 1 diabetes and celiac disease. The DCC has created a data warehouse architecture and informatics support for analysis of ?omics? data sets and will expand this by adding studies of the immune system and its role in the development of islet autoimmunity and T1D.