Clinical Trials Quality Assurance (CTQA) Program

A Quality Assurance (QA) program within the Office of Clinical Trials (OCT) that supports the investigator in ensuring that a clinical trial is conducted in accordance with federal, state, institutional regulations, and Good Clinical Practice (GCP). The CTQA assists researchers in setting up systems and processes prior to study initiation to ensure that all approvals and documentation are in place. The CTQA also completes post approval reviews (i.e., routine institutional reviews, Data and Safety Monitoring Plan (DSMP) reviews and reviews requested by investigators) and directed audits per the request of the Institutional Review Board (IRB) or the Office of the Vice Chancellor for Research (OVCR). UNC-Chapel Hill OVCR OCT: CTQA Program