# Clinical Core

> **NIH NIH P50** · YALE UNIVERSITY · 2020 · $359,052

## Abstract

Clinical Core
Stephanie S. O'Malley, Ph.D.
Abstract
The CTNA Clinical Core serves an important function as the central resource for the diverse clinical
projects and pilots. It represents the distinct advantage of an Alcohol Research Center over a cluster of
individual grants. The opportunity to fund a central facility with a distinguished leader provides a
programmatic method to define needs and assign resources to address central issues. The central
components of the Clinical Core are oversight of subject recruitment and clinical assessments, and data
management and analysis. The Core also oversees the creation of a cross-project “Core Database” for
investigating phenotypes relevant to the CTNA and its mission. The specific aims for this core are:
A. Centralized monitoring and recruitment of subjects to: 1) Enhance the efficiency of enrollment into each
 project, including pilots; and 2) Update the Principal Investigators (PIs), the Executive Committee, the
 Scientific Advisory Board, and the Data Safety Monitoring Board of progress on the protocols.
B. Central oversight of assessments to: 1) Provide efficiency in training and assessment; 2) Maintain
 consistency in the administration of assessments; 3) Enhance the ability of investigators to pool data across
 studies; 4) Insure that validated and current assessment tools are used; and 5) Support secondary analyses
 utilizing core assessments.
C. Central provision of data management and biostatistics support to: 1) Provide design and analytical
expertise to meet the goals of the CTNA scientific agenda; 2) Provide state-of-the-art methods for data
management; 3) Generate randomization lists and assess randomization implementation; 4) Interface with
specialized data analysis expertise related to particular technologies associated with the CTNA, including
genetics and imaging; 5) Prepare reports related to the progress of clinical studies for the Data Safety
Monitoring Board; and 6) Provide statistical support for all investigators.

## Key facts

- **NIH application ID:** 9940997
- **Project number:** 5P50AA012870-20
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** STEPHANIE S O'MALLEY
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $359,052
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9940997

## Citation

> US National Institutes of Health, RePORTER application 9940997, Clinical Core (5P50AA012870-20). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9940997. Licensed CC0.

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