Does a Mock Inspection Really Prove You’re Ready?

by: Paul DavidsonPublished on: 28/02/2026

Mock inspections are standard practice in regulated clinical research. They create activity, generate findings, and offer reassurance. But do they truly test whether your organisation is inspection ready, or do they simply re-document weaknesses you already suspected? In this month’s lead article, Gill and I challenge a common assumption: that rehearsing an inspection equates to resilience. Drawing on current regulatory expectations under ICH E6(R3) and practical experience across clinical environments, she explores the difference between superficial compliance and system capability. The piece examines what inspectors actually notice in the first hours of an inspection, why scripted answers and over-functioning QA departments are warning signs, and how leadership behaviour often determines inspection outcomes more than documentation alone. If inspection readiness is meant to be a state, not a project, this article invites clinical leaders to ask a more demanding question: does your system withstand pressure, or does it simply perform well in rehearsal?