# Biostatistics & Data Validation Core

> **NIH NIH P01** · NORTHWESTERN UNIVERSITY · 2023 · $273,723

## Abstract

Biostatistics and Data Validation Scientific Core: Abstract
The overall goal of the Biostatistics and Data Validation (BDV) Scientific Core is to ensure scientific rigor,
reliability of results, and reproducibility of research undertaken within the proposed Program, entitled, ‘Multi-
Scale Evaluation and Mitigation of Toxicities Following Internal Radionuclide Contamination’. While the
interdisciplinary nature and synergies of this Program are unique strengths, it can also present challenges for
integration between research projects at different institutions, particularly with regard to standardized data
management and statistical approaches. As such, the BDV Core will provide integrated support for statistical
design and analyses, source term characterization, data management, and validation of models and findings.
Principal Investigators (PIs) from collaborating institutions will have ready access to the team of biostatisticians,
radiation subject matter experts, and medical practitioners for the coordination, verification, and execution of
research experiments, data management, and analyses. The BDV Core will collaborate closely with research
project PIs to ensure that sound experimental designs, statistical methodologies, and radiological source terms
are utilized and documented, a critical factor in assuring that results are reliable and reproducible. A unique
aspect of this Core is the implementation of strategic validation and bench-marking processes, accomplished by
identifying appropriate datasets or results from literature, models, and other available sources for use in
sensitivity analyses and comparisons to confirm that inferences and results from the Program are consistent with
known or previously reported findings. This effort, coupled with clinical perspective provided by radiation
medicine experts, is critical to ensuring integrity of research results and products while promoting translation into
practice for in-field radiation protection, medical management of radiation exposure and injury, and use of
medical countermeasures. Further, centralized management of the Program data repository by the BDV Core,
with oversight from the Program Administrative Core, will ensure data integrity, accessibility, and version control.
In conclusion, the integrated expertise in biostatistics, radiation source term characterization, validation analyses,
and data management provided by the BDV Core will provide valuable scientific support for the successful
completion of the proposed research projects in the Program.

## Key facts

- **NIH application ID:** 10589868
- **Project number:** 5P01AI165380-02
- **Recipient organization:** NORTHWESTERN UNIVERSITY
- **Principal Investigator:** Ashley Golden
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $273,723
- **Award type:** 5
- **Project period:** 2022-03-10 → 2027-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10589868

## Citation

> US National Institutes of Health, RePORTER application 10589868, Biostatistics & Data Validation Core (5P01AI165380-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10589868. Licensed CC0.

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