# Core-004

> **NIH NIH UL1** · UNIV OF MASSACHUSETTS MED SCH WORCESTER · 2020 · $712,920

## Abstract

Robust research methods are fundamental for Clinical and Translational Research (CTR). Biostatistics and
Research Design (BERD) and the Regulatory Knowledge and Support (RKS) provide innovative, evidencebased
methods and processes that are key to UMass’ success in CTR.
BERD meets the ever-increasing need for thoughtful study design and analysis in an era where the quantity of
data available for CTR continues to explode and the seductiveness of easy-to-use and powerful analytic software
may lead to scientific findings that are less than reproducible. Educational efforts to help clinical and
translational researchers “know what they don’t know” and understand how to obtain support in these areas is
paramount. We propose a service-oriented BERD that provides state-of-the-art statistical and study design
consultation while also developing methodology and participating pro-actively in educational endeavors.
Study teams need to be familiar with the regulations guiding CTR. RKS ensures translational research quality
and integrity by providing a single integrated platform for proactive guidance and education, development of
innovative tools, and continuous process improvement to facilitate regulatory compliance with all applicable
rules and policies.

## Key facts

- **NIH application ID:** 10183467
- **Project number:** 2UL1TR001453-05A1
- **Recipient organization:** UNIV OF MASSACHUSETTS MED SCH WORCESTER
- **Principal Investigator:** Katherine F. Luzuriaga
- **Activity code:** UL1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $712,920
- **Award type:** 2
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10183467

## Citation

> US National Institutes of Health, RePORTER application 10183467, Core-004 (2UL1TR001453-05A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10183467. Licensed CC0.

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