# Regulatory Compliance Core

> **NIH NIH UC7** · BOSTON UNIVERSITY MEDICAL CAMPUS · 2020 · $361,920

## Abstract

Regulatory Compliance: Summary
The Regulatory Compliance group functions primarily as an independent Quality Assurance Unit (QAU)
providing oversight of all research functions in nonclinical studies as required by United States Food and Drug
Administration (FDA) Code of Federal Regulations chapter 21 part 58 (21 CFR Part 58). To serve in this
capacity, the Regulatory Compliance interim Core Director is coordinating the development and identifying the
elements of the pathway required to get the relevant necessary Cores in the NEIDL prepared to work in a Well
Documented and GLP environment. The specific aims of this core are to: 1) Monitor Well Documented and
GLP studies for accuracy and integrity of any data generated in such studies; 2) Conduct relevant Well
Documented and GLP compliance training for core directors and key staff; 3) Develop policies and procedures
pertaining to the Quality Assurance Unit; 4) Provide advice and oversight for equipment procurement and
facility commissioning activities. The Regulatory Compliance group will work in conjunction with the Study
Director and Integrated Support Services Cores to coordinate all research functions in support of Study
Protocols for Well Documented and GLP studies.

## Key facts

- **NIH application ID:** 9939431
- **Project number:** 5UC7AI095321-07
- **Recipient organization:** BOSTON UNIVERSITY MEDICAL CAMPUS
- **Principal Investigator:** Jacob Koster
- **Activity code:** UC7 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $361,920
- **Award type:** 5
- **Project period:** — → 2021-07-07

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9939431

## Citation

> US National Institutes of Health, RePORTER application 9939431, Regulatory Compliance Core (5UC7AI095321-07). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9939431. Licensed CC0.

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