Clinical Trials Quality Assurance (CTQA)
The Clinical Trials Quality Assurance (CTQA) Program is committed to assisting investigators in maintaining the highest standards of quality and compliance throughout their clinical research. The CTQA offers the following resources and support:
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 an informal 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-Chapel Hill). These internal reviews are intended to help investigators assess compliance with all applicable federal and state laws, regulations, and institutional policies.
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.
The CTQA is the 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.
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:
The CTQA team will provide support to investigators during sponsor-conducted independent audits, which are distinct from routine monitoring functions. This support includes evaluating compliance with the study protocol, Standard Operating Procedures (SOPs), ICH E6 R2 Good Clinical Practices, and any applicable regulatory requirements.
The CTQA team will 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.
External monitoring letters and audit reports must be submitted to the CTQA at the time of continuing review. The CTQA team will 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 these FAQs
Coming soon!
For essential documents templates, please visit the CRCO Forms & Templates Library
Below are some key resources to assist you:
- CTQA Common Audit Findings Presentation
- Examples of Root Cause Analysis Methods
- Root Cause Analysis Template
For essential documents templates, please visit the CRCO Forms & Templates Library
Have Questions for the CTQA Team?
We’re here to assist you! Feel free to email us at ctqa@unc.edu.