Clinical Trials Quality Assurance Program (CTQA)

The Clinical Trials Quality Assurance (CTQA) Program is dedicated to supporting investigators in achieving the highest standards of quality and compliance in their clinical research. Our mission is to ensure that all clinical trials conducted at UNC adhere to federal, state, and institutional regulations, thereby safeguarding the integrity of research and the safety of participants.

Our Services & Resources

Quality Assurance Reviews

We assist research teams in establishing systems and processes at the outset of a trial, ensuring that regulatory requirements are fulfilled, and essential documents are in place (i.e., documentation of investigators qualifications, confirming Delegation logs are accurately completed, assisting with training documentation).

Throughout the study, we conduct informal reviews to check for compliance and provide feedback. Suggestions or assistance is offered (if needed) to help the team maintain compliance.

We conduct internal reviews of a percentage of clinical research projects to ensure ongoing compliance with all applicable laws and policies.

FDA or External Agency Inspections

We act as a liaison between the research investigator and the agency inspector. The CTQA team notifies the appropriate University offices, organizes files, takes notes during the inspection and documents any line of questioning from the inspector, and assists with any response necessary at the end of the inspection.

An inspection, in the context of clinical research, involves a thorough examination of the research processes, documentation, and compliance with applicable laws and regulations. These inspections are conducted by agencies such as the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), European Medicines Agency (EMA), Health Canada, and other regulatory bodies. The most common agency inspections at UNC are conducted by the FDA.

If you are notified of any inspection, please email us at ctqa@unc.edu.

Below are essential resources to help you prepare for and navigate FDA inspections:

• FDA Inspections Presentation
• FDA guidance on Investigator Responsibilities
• Guidance for Research Sponsor Request for Information Related to FDA Inspections

Sponsor Audits

We provide support to investigators during sponsor-conducted audits, which are distinct from routine monitoring functions. Our team evaluates compliance with the study protocol, Standard Operating Procedures (SOPs), ICH E6 R2 Good Clinical Practices, and any applicable regulatory requirements. We assist in organizing necessary documentation, preparing for the audit, and addressing any findings or recommendations from the sponsor to ensure the study meets all required standards.

Monitoring Letters/Audit Reports

External monitoring letters and audit reports must be submitted to the CTQA at the time of continuing review. We compile these findings into a database to track trends and identify educational opportunities throughout the University. For more information about the submission of monitoring letters and audit reports, please refer to our FAQs.

Resources

• Self-Assessment Series
• CTQA Common Audit Findings Presentation
• Examples of Root Cause Analysis Methods
• Root Cause Analysis Template

For additional resources, please visit the CRCO Resource page.

Contact Us

We are committed to excellence in clinical research and are here to assist you every step of the way. For more information or assistance, please contact us at ctqa@unc.edu.