# Administrative Core

> **NIH NIH U19** · YALE UNIVERSITY · 2021 · $808,494

## 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
Coordinating Core (DCC) will provide a secure informatics infrastructure for communication and data integration
across the consortium to ensure organized data management, quality control, and reliable upload to the National
Database for Autism Research (NDAR) and NIH Data Repositories. 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 will oversee the operations of the sites, the DCC, and the
DAAC to ensure methodologically and ethically rigorous, efficient completion of study aims and to coordinate
with federal partners in this cooperative agreement by: 1) Coordinating communication and data sharing to
manage all aspects of the project, including recruitment and data collection, data management and quality
control, standardization of data acquisition and processing, analytic planning, and financial management; 2)
Administering the consortium project across all sites and cores in terms of managing the central institutional
review board, developing and disseminating Standard Operating Procedures, implementing Good Clinical
Practice, maintaining research fidelity, overseeing quality control, and planning timely upload to NIH/NIMH Data
Repositories; 3) Maintaining appropriate communication and integrating feedback from federal partners,
executing the finalized protocol as per the collaborative agreement, and planning Steering Committee meetings
and annual in-person meetings.

## Key facts

- **NIH application ID:** 10224932
- **Project number:** 5U19MH108206-06
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** James Charles McPartland
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $808,494
- **Award type:** 5
- **Project period:** 2015-07-17 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10224932

## Citation

> US National Institutes of Health, RePORTER application 10224932, Administrative Core (5U19MH108206-06). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10224932. Licensed CC0.

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