# Follow-up on Subjects, Integrative Data Analysis and Measurement of Viral Antibodies in The Environmental Determinants of Diabetes in The Young Study (TEDDY)

> **NIH NIH U01** · UNIVERSITY OF SOUTH FLORIDA · 2020 · $1,124,836

## 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 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...

## Key facts

- **NIH application ID:** 10260891
- **Project number:** 3U01DK124166-01S1
- **Recipient organization:** UNIVERSITY OF SOUTH FLORIDA
- **Principal Investigator:** JEFFREY P KRISCHER
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,124,836
- **Award type:** 3
- **Project period:** 2020-09-14 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10260891

## Citation

> US National Institutes of Health, RePORTER application 10260891, Follow-up on Subjects, Integrative Data Analysis and Measurement of Viral Antibodies in The Environmental Determinants of Diabetes in The Young Study (TEDDY) (3U01DK124166-01S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10260891. Licensed CC0.

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