# Down Syndrome Clinical Cohort Coordinating Center (DS-4C) for the INCLUDE Project

> **NIH NIH U54** · RESEARCH TRIANGLE INSTITUTE · 2024 · $100,862

## Abstract

PROJECT SUMMARY/ABSTRACT
The overarching goal of the proposed INCLUDE Clinical Cohort Coordinating Center (DS-4C), co-led by
investigators at RTI International and Emory University, is to improve the health and well-being of individuals
with Down syndrome (DS) by supporting the INCLUDE Project’s DS Cohort Development Program (DS-CDP).
In this capacity, the DS-4C will serve as the central hub for orchestrating and integrating all components of the
DS-CDP, including overseeing the development and implementation of a common protocol to guide
harmonized data collection across multiple DS Cohort Research Sites (DS-CRS) in the DS-CDP and
facilitating data transfer into the INCLUDE Data Coordinating Center (DCC) and Data Hub for availability to
researchers. The complex structure of the DS-CDP requires the DS-4C’s expert leadership and coordination to
generate an effective, integrated, unified network to achieve the goal of generating deep phenotyping data and
collecting biospecimens in a large, diverse cohort of individuals with DS across the lifespan to support future
research efforts to improve DS-associated co-morbidities. The four cores of the DS-4C (Administrative, Cohort,
Outreach, and Data Management) will leverage the expertise of core staff and work collaboratively to provide
administrative support to facilitate collaboration and communication across the DS-CDP; ensure seamless
implementation of the protocol; implement and support inclusive outreach efforts to facilitate inclusion and
representation in recruitment; and manage the flow of data and biospecimens from the DS-CRS to the
INCLUDE DCC and Data Hub and DS-Biorepository, respectively. Our specific aims are as follows:
Aim 1: Implement tools and systems to foster seamless integration and operational efficiency within the DS-4C
and across the DS-CDP.
Aim 2: Provide expertise and resources to develop and implement the common protocol across the DS-CDP
while enhancing the scientific rigor of DS-CRS studies to maximize the scientific impact of the INCLUDE Project.
Aim 3: Enhance community engagement, facilitate recruitment of participants and team members from typically
underrepresented groups, advance health equity goals, and promote awareness of the INCLUDE Program.
Aim 4: Manage the flow of data from DS-CRS into the INCLUDE DCC and Data Hub for access by the DS
research community.
The DS-4C will be led by Multiple Principal Investigators, Dr. Hunter at RTI and Dr. Rosser at Emory, with a
collaborative history and extensive expertise in elucidating health outcomes of individuals with DS through
phenotypic protocol development, biospecimen collection, multi-site recruitment efforts, and data
harmonization. The proposed DS-4C is immediately and amply prepared to support its mission to develop
clinically meaningful findings that positively impact those affected by DS.

## Key facts

- **NIH application ID:** 11015425
- **Project number:** 1U54HL178351-01
- **Recipient organization:** RESEARCH TRIANGLE INSTITUTE
- **Principal Investigator:** Emily Graves Allen
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $100,862
- **Award type:** 1
- **Project period:** 2024-09-20 → 2029-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11015425

## Citation

> US National Institutes of Health, RePORTER application 11015425, Down Syndrome Clinical Cohort Coordinating Center (DS-4C) for the INCLUDE Project (1U54HL178351-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/11015425. Licensed CC0.

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