The University of North Carolina at Chapel Hill is committed to the highest standards of regulatory compliance and data integrity in clinical research. This page contains official position statements that articulate our approach to best practices, regulatory expectations, and the ongoing enhancement of clinical research.

Position Statement (December 2024): Part 11 Compliant Regulatory System for Clinical Trials at the University of North Carolina at Chapel Hill

This statement outlines UNC-Chapel Hill’s position on using FDA-compliant electronic systems to manage clinical trial documentation securely and efficiently.

Position Statement (May 2024): Standardized Subject Injury Language for Industry-Sponsored Clinical Trials

This statement outlines UNC-Chapel Hill’s standardized approach to subject injury language used in informed consent documents for industry-sponsored clinical research.