# Core G: Biostatistics and Data Management

> **NIH NIH U19** · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2021 · $1,942,547

## Abstract

Biostatistics and Data Management Core Abstract
The Biostatistics and Data Management (BDM) Core facilitates research and collaboration with ABC-DS
investigators by providing data management, epidemiological, analytic design and statistical support, and by
creating an infrastructure for data sharing with the research community to further the understanding of
Alzheimer’s Disease and Down syndrome. BDM Core personnel, lead by Drs. Tudorascu (statistics) and
Andrews (data management) will support the ABC-DS Cores leaders and investigators in fulfilling the specific
aims of Research Projects 1, 2 and 3 by establishing a secure, centralized online data management system,
implementing a protocol to ensure the integration and documentation of clinical, neuroimaging, omics, genetic
and neuropathology data and providing high-level statistical support, with expertise required to test each stated
hypothesis in this project. These functions will be carried out through a multidisciplinary team of Biostatistics
Methodology Groups (BMGs): statisticians, epidemiologists, and data management experts organized into
groups, each with specific expertise and unique skills that can be used across several Projects and Cores. The
Specific Aims that will be implemented using this organizational structure are as follows: Aim 1: Complete the
transition to a unified relational database and project management system by harmonizing and integrating
evaluation data across all Performance sites, incorporating the new, unified evaluation protocol, and providing
functionality for scheduling and documenting all study procedures and integrating key data elements from the
Clinical, Neuropathology, Omics, ADDORE and Neuroimaging Core; Aim 2: Create a set of analytic data files
containing all original and derived data elements from all sources necessary for the statistical analysis required
to test the hypotheses of each Research Project in this proposal, as well as create data sets meeting
specifications for any secondary and ad hoc analyses planned during the conduct of this research; Aim 3: Lead
the statistical data analyses, collaborate in report preparation for all Cores and Research Projects, and provide
expertise on design and methodological aspects of statistical analyses for ABC-DS Research Projects; Aim 4:
Develop and implement appropriate statistical models for longitudinal analyses of derived biomarkers from all
modalities in order to make inferences with respect to impact at each stage of the development of AD in our
cohort of adults with DS; Aim 5: Facilitate sharing of ABC-DS data through the Laboratory of Neuroimaging
(LONI), serve as a methodological resource for researchers within and outside of ABC-DS interested in using
the ABC-DS database for analyses, and provide documentation and ensure reproducibility of published ABC-
DS research.

## Key facts

- **NIH application ID:** 10264841
- **Project number:** 5U19AG068054-02
- **Recipient organization:** UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- **Principal Investigator:** Dana L Tudorascu
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,942,547
- **Award type:** 5
- **Project period:** 2020-09-30 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10264841

## Citation

> US National Institutes of Health, RePORTER application 10264841, Core G: Biostatistics and Data Management (5U19AG068054-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10264841. Licensed CC0.

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