Clinical Trials Quality Assurance (CTQA) Program

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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 to help the team (if needed) 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.

CTQA staff also offer support to investigators when an external inspection – such as a sponsor or 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/auditor, and assist with any response necessary at the end of the inspection.

The CTQA staff also reviews compliance with Good Clinical Practice (GCP) training for those studies in which GCP training is required (studies that involved human subjects AND a drug, device or biologic).  This review happens prior to the PS Project ID assignment.  Information on GCP training requirements can be found here.

If you would like more information on the CTQA program or GCP training, please contact Valorie Buchholz, Associate Director at 919-445-9355 (buchholz@unc.edu) or The Office of Clinical Trials at 919-843-2698 (oct@unc.edu).