The University of South Florida is uniquely qualified to conduct the activities specified in this limited competition RFA. The proposed Data Coordinating Center activities described 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 bio-sample 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 bio-samples 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 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. Identification of such factors will lead to a better understanding of disease pathogenesis and result in new strategies to prevent, delay or reverse T1D. 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 micro-biome in assessing characteristics of those developing autoimmunity, Type 1 diabetes and celiac disease.
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