# 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)

> **NIH NIH U01** · UNIVERSITY OF SOUTH FLORIDA · 2021 · $28,378,781

## Abstract

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 ...

## Key facts

- **NIH application ID:** 10227415
- **Project number:** 1U01DK128847-01
- **Recipient organization:** UNIVERSITY OF SOUTH FLORIDA
- **Principal Investigator:** JEFFREY P KRISCHER
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $28,378,781
- **Award type:** 1
- **Project period:** 2021-04-28 → 2025-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10227415

## Citation

> US National Institutes of Health, RePORTER application 10227415, 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) (1U01DK128847-01). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10227415. Licensed CC0.

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