Audits & Inspections
Quality Assurance Reviews
The Clinical Trials Quality Assurance (CTQA) Program is designed to support investigators in ensuring their trials are conducted in accordance with federal, state, and institutional regulations.
The CTQA staff can assist with setting up systems and processes at the beginning of a trial to validate all the regulatory requirements and essential documents are in place (i.e., documentation of investigators qualifications, confirming Delegation logs are accurately completed, assisting with training documentation).
During the study, CTQA staff can work with the study team in doing a “friendly review” to check for compliance. Once completed, any findings are reviewed with the study team. Suggestions or assistance is offered (if needed) to help the team ensure continuing compliance.
The CTQA Program will also conduct post approval reviews for a percentage of clinical research involving human subjects at the University of North Carolina at Chapel Hill (UNC-CH). These reviews are intended to assist investigators in evaluating compliance with all applicable laws and regulations as well as institutional policies for their studies.
If you would like more information on the CTQA program, please contact the Office of Clinical Trials at 919-843-2698 (CTQA@unc.edu)
- CTQA Frequently Asked Questions (FAQ)
- CTQA Common Audit Findings Presentation
- Examples of Root Cause Analysis Methods
- Root Cause Analysis Template
FDA Inspections
The CTQA staff offers support to investigators when an FDA inspection occurs. Assistance is provided to notify the appropriate University offices, organize files, take notes during the inspection and document any line of questioning from the inspector, and assist with any response necessary at the end of the inspection.
If you are notified of an FDA inspection (or other regulatory agency), please contact the Office of Clinical Trials at 919-843-2698.
- FDA Inspections Presentation
- FDA guidance on Investigator Responsibilities
- Guidance for Research Sponsor Request for Information Related to FDA Inspections
Sponsor Audits
The CTQA Staff will provide support to investigators when a sponsor conducts an independent audit, which is separate from routine monitoring functions. Assistance will be provided to evaluate compliance with the protocol, SOPs, GCP and any applicable regulatory requirements.
Monitoring Letter Review
The CTQA staff review and record information obtained from external monitoring letters received from UNC-CH research staff at the time of continuing review. The findings will be compiled into a database for tracking and trending findings for educational opportunities throughout the University.