Data Coordinating Center for Type 1 Diabetes TrialNet

NIH RePORTER · NIH · U01 · $2,792,647 · view on reporter.nih.gov ↗

Abstract

Project Summary/Abstract This application requests support for the continuing operations of the TrialNet Coordinating Center (TNCC) at the University of South Florida. The University of South Florida has served as the Coordinating Center for TrialNet since October, 2008. The primary objective of TrialNet is to prevent or delay initial onset and/or progression of type 1 diabetes (T1D) by preserving insulin-producing beta cells in individuals at elevated risk and those who have been newly diagnosed with T1DM. To achieve this goal, TrialNet designs and implements prevention and interventional clinical trials intended to test treatments that may preserve remaining insulin secretion in recently diagnosed individuals (new-onsets). The TNCC provides epidemiological, biostatistical, operational and administrative expertise and advice to the clinical centers, reference laboratories and the NIDDK which include the following tasks: 1) study-wide communications, procurement and dissemination of study materials, and related activities 2) data management and records maintenance; 3) clinical site and central laboratories monitoring; 4) data analyses; 5) preparation of study reports and papers for publication; 6) implementation of procedures to evaluate management, methodology, and cost- effectiveness of procedures utilized by the TNCC; and 7) periodic meetings. This application provides support for enhancements and upgrades for communication, data collection, editing, processing, analysis, and reporting for TrialNet studies and operations including data quality, protocol adherence and data confidentiality, and provide for implementation and procedures for coordinating submission of samples and data from the participating Clinical and Affiliate Centers to the TrialNet Central Laboratories and NIDDK Repository.

Key facts

NIH application ID
10261304
Project number
3U01DK106993-03S2
Recipient
UNIVERSITY OF SOUTH FLORIDA
Principal Investigator
JEFFREY P KRISCHER
Activity code
U01
Funding institute
NIH
Fiscal year
2020
Award amount
$2,792,647
Award type
3
Project period
2015-09-30 → 2024-06-30