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, Pharm.D., Ph.D., and other contributors including RKS Associate Director Nancy Pire-Smerkanich, D.R.Sc., M.S., and Administrators Karen Manrique, M.S., Annie Ly, M.S., Roxy Terteryan, M.P.H., 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…
Read the full article here.
