# Evaluating New Nicotine Standards for Cigarettes - Core C

> **NIH NIH U54** · WAKE FOREST UNIVERSITY HEALTH SCIENCES · 2022 · $219,261

## Abstract

Core C – Biostatistics and Data Management 
The Biostatistics and Data Management Core provides a broad array of statistical services in support of the 
three Projects. The Core will provide advice on experimental design - such as selection of end points and 
possible stratification, consideration and calculation of sample size and statistical power. The Core is 
responsible for all aspects of data management in a secure central database with strong emphasis of data 
integrity and quality. The Core will form plans and perform expert statistical analyses in a format consistent 
between Projects using techniques that are state of the art in practice. The Core will also facilitate data sharing 
between projects in the Program as well as the general scientific community following NIH guidelines. 
The Core is staffed by one biostatistician serving as Protocol Manager (Data Manager) and three highly 
experienced biostatisticians who have daily working relationships with the Project investigators. The Core 
biostatisticians have been an integral part in the development of the proposed Program and have participated 
with this group of investigators the last 4-5 years of this current CENIC grant. 
The primary objective of the Biostatistics and Data Management Core is to contribute to the science and 
operation of the center by participating fully in its activities. Core Statisticians have broad long-standing 
expertise in experimental design, data collection, data storage, data analysis, and interpretation of results 
incorporating novel and complex statistical procedures as needed. By providing expertise research 
methodology and logistical support to data analytic activities with each Project, this Core will enhance data 
interpretation and scientific productivity.

## Key facts

- **NIH application ID:** 10122932
- **Project number:** 5U54DA031659-10
- **Recipient organization:** WAKE FOREST UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** CHAP T. LE
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $219,261
- **Award type:** 5
- **Project period:** 2020-03-01 → 2025-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10122932

## Citation

> US National Institutes of Health, RePORTER application 10122932, Evaluating New Nicotine Standards for Cigarettes - Core C (5U54DA031659-10). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10122932. Licensed CC0.

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