Inspection
In Oversight, quality & inspection
Also known as: regulatory inspection, GCP inspection
An inspection is an official review conducted by a regulatory authority of trial-related sites, documents, facilities, and records. Unlike an audit, it is carried out by the regulator and can lead to formal regulatory consequences. Inspections may be routine, triggered by a submission, or prompted by a specific concern.
Why it matters
Everything a site does is ultimately built for this moment: can an independent official reconstruct what happened to each participant from the records alone?
Example
A regulator selects a site that enrolled a large share of participants in a pivotal trial and reviews its consent forms, source documents, and drug-accountability records against the submitted data.
Related terms
Turn the vocabulary into a career
The free CRLN Career Finder maps your background to a clinical-research role and builds a step-by-step roadmap. No cost, no card.
Get your free roadmap →Educational reference only. Where regional rules differ, follow the regulation and the written procedures that apply where you work.