Limited Competition: Continued Follow-up of Subjects and Initiation of a Second Case-control Cohort in The Environmental Determinants of Diabetes in The Young Study (TEDDY)

Project Summary/Abstract 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 initiate a second nested case-control cohort.

Plans to continue the DCC's functions in support of TEDDY subject follow-up include: 1) Supporting the execution of the study protocol for follow-up of TEDDY study participants 2) Receiving, managing, and analyzing data obtained from the TEDDY Clinical Centers 3) Protecting patient confidentiality at all steps in the submission and analysis of the data and ensuring the technical integrity and security of the data management systems 4) 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 for overseeing data quality control 5) Providing statistical support, expertise and oversight throughout the study; collaborating with the clinical investigators in the preparation of presentations and primary and secondary publications; and providing additional analyses at the request of the External Evaluation Committee (EEC) or the NIDDK 6) 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 7) 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 8) Procurement and administration of subcontracts for laboratory and repository services.

Through subcontracts the DCC will also provide capitated reimbursements to the Clinical Centers for study visits and procedures, including data and biosample acquisition, and other necessary services for conduct of the study 9) 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.

It will also be responsible for preparing reports for and organizing meetings of an External Evaluation Committee (EEC) convened by NIDDK. 10) Ensuring the transfer of all biosamples and data to the NIDDK designated repositories.

It is responsible for supporting and promoting data sharing by preparing a limited personal health information or de- identified data set in a format appropriate for data sharing for submission to a secure NIDDK data repository after publication of the primary and other study results or 12 months after completion of data collection for the primary endpoint.

Plans to initiate a second nested case-control cohort will mirror the first case-control cohort and will afford the opportunity to generate data of a variety of different data types across all ages of the TEDDY study population.