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Quality Assurance & Compliance

Coordinating Excellence Across University Research Divisions Through Collaborative Quality Management and Standardized Principles

Empowering Research Through Quality

The Office of Research and Partnerships (ORP) Quality and Compliance audit teams 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.


Goals of an Internal Wellness Check

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: Adherence to institutional protocols/amendments, institutional policies, and applicable federal regulations. 
This includes ICH GCP (international Council for Harmonisation - Good Clinical Practice), which is the global gold standard rulebook for running safe, high-quality clinical trials.
 

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 University of Arizona 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.

IRB QA Focus

  •  Protocol Review Quality Standards
  • Informed Consent Compliance
  • Continuing Review Processes
  • Adverse Event Reporting
  • Regulatory Compliance Auditing

Cancer Center QA Focus

  • Oncology Clinical Trial Compliance
  • Biospecimen Quality Management
  • FDA/NCI Regulatory Compliance
  • Patient Safety Protocols

CATS QA Focus

  • Consulting support in the early stages of protocol development
  • Nursing and Coordinator services
  • Scheduling diagnostic tests and services
  • Regulatory monitoring
  • Lab services
  • Research Training