SC CTSI Regulatory Knowledge and Support Core Launches New Module on Site Preparedness for FDA Inspection

The SC CTSI Regulatory Knowledge and Support (RKS) group has launched their final installment of “Clinical Trial Quality Training Series” with the release of the third module, “Site Preparedness for FDA Inspection."

by Annie Ly — May 20, 2024
Clinical Trial Quality Training Series Module III: Site Preparedness for FDA Inspection

This open-access, self-study module series was created to address the need for quality management across the clinical trial lifecycle, as emphasized in the recent addendum to the ICH Guideline for Good Clinical Practice (GCP), E6(R2). The first two modules in this series cover monitoring and auditing clinical research sites. This third module is designed to provide the clinical research workforce with a fundamental understanding of the best practices for site inspections by the U.S. Food and Drug Administration (FDA). It also covers important factors and activities that the clinical research site staff should consider and complete before, during, and after the inspection. Additionally, the module provides guidance on what to do in case of receiving an FDA Form 483 and provides real scenarios with case studies.

The RKS team spent around a year working on a module about site inspections conducted by the FDA. This module project was led by RKS Director, Chair and Associate Professor, Eunjoo Pacifici, PharmD, PhD, and other contributors including RKS Associate Director Nancy Pire-Smerkanich, DRSc, MS, and Administrators Karen Manrique, MS, Annie Ly, MS, Roxy Terteryan, MPH, and Gordon Wimpress. The team extracted content from various sources, such as the FDA, the National Institutes of Health, clinical research organizations, and the expertise and experiences of key stakeholders within the RKS group.

The content was then recorded, edited, and produced by RKS Project Administrator Gordon Wimpress. The module is free and self-paced, and it is open to the entire clinical research workforce, as well as anyone interested in learning more about FDA site inspections. Upon completion of any of the modules, users receive a digital badge and a certificate of completion, which can be a great addition to resumes, CVs, and LinkedIn profiles.

To access this new module, please visit, sign in or create a new profile, navigate to the Course Catalog for USC Regulatory Science/SC CTSI, and choose “Site Preparedness for FDA Inspection.”

NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.