# NIDDK OCRS Clinical Consortium Audit Support

> **NIH NIH N02** · — · 2021 · $185,152

## Abstract

A National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) extramurally funded consortium initially conducted a multi-center randomized clinical trial with a Coordinating Center and 20-some clinical centers and then transitioned to a long-term follow-up protocol. Participants are being followed for long-term health outcomes and have two visits each year. The initial clinical trial operated under an Food and Drug Administration (FDA) Investigational New Drug (IND). The IND was withdrawn during the follow-up period, and then a new IND put in place later during that period when the study drug supplier was changed to a supplier that had not been inspected by the FDA. The NIDDK recently learned that an Institutional Review Board (IRB) at one of the clinical centers had identified a potential issue of noncompliance relative to Federal regulations and (Good Clinical Practice) GCP guidelines. NIDDK leadership and Office of Clinical Research Support (OCRS) personnel consulted with extramural staff and relevant NIH offices and then decided that an independent ‘for cause’ assessment to address both funder and sponsor responsibilities should be conducted.

## Key facts

- **NIH application ID:** 10498366
- **Project number:** 75N94021P00907-0-0-1
- **Recipient organization:** —
- **Principal Investigator:** SEUN OYEWO
- **Activity code:** N02 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $185,152
- **Award type:** —
- **Project period:** 2021-09-22 → 2022-03-21

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10498366

## Citation

> US National Institutes of Health, RePORTER application 10498366, NIDDK OCRS Clinical Consortium Audit Support (75N94021P00907-0-0-1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10498366. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*