Quality Assurance Program

The Office of Research Compliance and the Human Research Projection Program is excited to implement the Quality Assurance program. The QA program seeks to ensure continued investigator and institutional review board compliance with federal and state regulations governing human research, and is independent from the IRB. The program acts as a liaison between investigators and the IRB.

The Office of Research Quality Assurance program’s mission is fulfilled by working with investigators to help them identify gaps that might negatively impact their research and assist them by making recommendations to eliminate these gaps through education and guidance to achieve ongoing compliance throughout the life of anyone study.

For questions regarding quality assurance program, please contact QAprogram@tcu.edu

The main goals of the program are:

1. To ensure research is being conducted in accordance with federal regulations governing the protection of research participants, TCU policy and procedures, and good clinical practice (GCP) guidelines (as applicable).
2. To provide researchers a review of their research procedures, determining from a source other than the investigator’s continuing review or annual check-in, that no material changes have occurred in the project since the IRB previous review.
3. To provide researchers with one-on-one and group educational activities regarding human subject research.
4. To facilitate communication between the IRB/ HRPP and researchers at TCU.

Service of the Quality Assurance Program:

• Routine, on-site Quality Assurance Reviews
• Assistance with when/what to report and recordkeeping
• Random, Internal reviews of approved IRB protocol
• Development of QA tools and training
• Random Review of IRB meeting minutes and Reviewer Checklist
• Compliance Follow-up of IRB protocols

Helpful Links:

• Study Start-Up Tool Kit
• Self-Audit Tool kit
• Clinical Trial Resources