# Data Coordinating Core

> **NIH NIH U19** · YALE UNIVERSITY · 2024 · $831,148

## Abstract

Project Summary/Abstract
The ongoing goal of the Autism Biomarkers Consortium for Clinical Trials (ABC-CT) is to establish
electroencephalography (EEG) and eye-tracking (ET) biomarkers that can be used for stratification and/or as
sensitive and reliable objective assays related to social function in autism spectrum disorder (ASD) clinical trials.
This renewal application seeks to further validate promising measures through three studies designed to
enhance and extend the original ABC-CT study: (1) a confirmation study of the original findings in a new cohort
using similar design (T1: Baseline, T2: 6 weeks post baseline, T3: 24 weeks post baseline) and sample
size/characteristics (200 with ASD, 200 with typical development (TD)); (2) a follow-up study of the original cohort
(N=399) to re-administer the biomarker and clinical batteries 2.5-4 years after original ABC-CT enrollment; (3) a
feasibility study of parallel EEG and ET biomarkers in preschool-aged (3-5-year-old) children (25 with ASD, 25
with TD). The biomarker and clinical batteries measure key facets of social-communication in ASD using well-
validated paradigms appropriate for the intended developmental and cognitive range. The study will rely on the
same leadership and five Collaborating Implementation Sites (“Sites”) from the first phase, all highly experienced
in multi-site collaborative clinical research using the proposed clinical, EEG, and ET methodologies. The Data
Acquisition and Analysis Core (DAAC) will oversee consistent use of scientific standards and methodological
rigor for data acquisition, processing, and analytics. The Administrative Core, in coordination with federal
partners in this cooperative agreement, will oversee the operations of the sites, Data Coordinating Core (DCC),
and DAAC to ensure methodologically and ethically rigorous, efficient completion of scientific aims. The DCC
will utilize informatics and technology to develop, maintain, and monitor a robust, secure, HIPAA-compliant data
collection, coordination, and storage system to streamline communication and data flow throughout the
consortium and ensure organized, secure data management, quality control, and reliable upload to the National
Database for Autism Research and NIH/NIMH Data Repositories. The DCC benefits from the Yale Center for
Clinical Investigation’s data coordinating and quality assurance experience. The DCC will: 1) anticipate, respond
to, and fulfill the informatics needs of the consortium in the design, harmonization, and implementation of data
coordination and innovative data collection methods and tools across consortium components and studies for
collection and management of EEG, ET, and clinical measures; 2) provide state-of-the-art methods in support of
these studies for: a) consortium communication; b) data management, site monitoring, privacy, and security
within the consortium and across sites; and c) the dissemination of information to stakeholders.

## Key facts

- **NIH application ID:** 10880331
- **Project number:** 5U19MH108206-09
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** James David Dziura
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $831,148
- **Award type:** 5
- **Project period:** 2015-07-17 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10880331

## Citation

> US National Institutes of Health, RePORTER application 10880331, Data Coordinating Core (5U19MH108206-09). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10880331. Licensed CC0.

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