The clinical investigator site audit – process‐driven good clinical practice

Abstract

This article describes a process-driven approach to the conduct of a Good Clinical Practice (GCP) audit at a clinical investigator site and to the assessment of systemic GCP compliance in just a few days with little or no background information. The technique involves looking at the site and resulting observations from a system-related point of view, with the primary goal of finding flaws in methods of operation as opposed to looking for isolated errors. Then, expanding the impact of corrective actions to the maximum extent (i.e. to all systemic flaws). To put it simply, it is a process-driven approach with the ultimate goal of getting the GCP system under satisfactory control. Copyright © 2008 John Wiley & Sons, Ltd.