The University of Tennessee Graduate School of Medicine, Knoxville

Quality Assurance and Monitoring Post IRB Approval

University of Tennessee Graduate School of Medicine Faculty, or University of Tennessee Medical Center Clinicians engaging in Investigator-Initiated Research, that requires the use of a written Informed Consent form (ICF), will require Routine Monitoring for Quality Assurance and Compliance.

A Quality Assurance and Monitoring Plan Strategy IS NOT REQUIRED for low-risk studies that do not require the informed consent of patients. GSM SOP's and Good Clinical Practice will still be applicable via Investigator oversight. Once the PI obtains IRB approval, and if the approved projects meet the stated criteria, the IRB office will send notifications via email to the UTGSM Assistant Director of Research and UHS Executive Director of Research/ OCT Director, and they will initiate contact with the PI to discuss potential monitoring pathways.

For more information, UTGSM Faculty contact:
Jennifer Ferris, MSHS, CCRC, Director of Research
Phone: (865) 305-7975, jferris@utmck.edu
OR
Brandy Herbert MBA, BSN, RN, Director, Office of Clinical Trials
Phone: (865) 305-5120, bherbert@utmck.edu.

Quality Assurance Pathway Tool (Word Document)

Quality Assurance Pathway Flowchart