Quality Assurance/Post Approval Monitoring Program

Supporting Human Research Compliance and Quality Improvement

The Quality Assurance/Post-Approval Monitoring Program is part of the Human Research Protection Program. The program supports investigators and study teams by promoting participant protection, regulatory compliance, and continuous quality improvement in human research.

Post-approval monitoring is designed to be collaborative, educational, and risk-informed. The goal is to help study teams conduct research consistent with IRB approval, institutional requirements, and applicable regulations.

Program Activities

The Quality Assurance/Post-Approval Monitoring team may:

• Conduct post-approval monitoring of active human research studies.
• Provide education and guidance to investigators and study teams.
• Identify opportunities to improve study documentation and research processes.
• Support HRPP and IRB quality improvement efforts.

Monitoring activities may vary based on the nature of the study and the purpose of the review.

Review Process

When a study is selected for review, the study team will be contacted with additional information. Reviews may include discussion with study personnel and review of relevant study materials.

Following the review, the study team will receive feedback. Feedback may include observations, recommendations, or follow-up items intended to support compliance and improve study conduct.

Preparing for Monitoring

Study teams should maintain complete and organized research records throughout the life of the study. If contacted for a review, the study team should be prepared to provide requested materials and discuss study activities with the Quality Assurance/Post-Approval Monitoring team.