Quality Assurance & Compliance

Introduction and Purpose

The Office of Research and Partnerships (ORP) Quality and Compliance audit team serve as a resource to the University of Arizona (UA) research community by providing centralized internal auditing to support the adherence to the core principles of research best practices. Our mission is to take a collaborative approach with UA study teams by considering these audits as study wellness checks.

All research involving human subjects at the University of Arizona is subject to review and inspection at any time and may benefit from internal review.

The purpose of an internal wellness check is to ensure:
• Human subject protection: The safety, welfare, and rights of human subjects are protected.
• Data integrity and study validity: Data are reliable, accurate, complete, and verified from source documentation
• Compliance with University of Arizona IRB approved protocol(s)/amendment(s); with ICH GCP; institutional policies and procedures; and applicable laws, federal regulations, and guidance.

Wellness checks promote continuous quality improvement opportunities by providing increased awareness and understanding of regulatory obligations; clinical trial support and serving as a resource to study teams; and constructive feedback.

Collaborative Quality Framework

The UA operates under a distributed quality model where specialized QA departments within each research unit maintains autonomy while adhering to overarching institutional quality principles. This approach ensures both expertise-specific quality control and university wide consistency.

Our collaborative quality network connects independent QA departments across divisions. Each unit operates independently while collaborating on university wide quality initiatives and standards harmonization