CT09: Good Clinical Practice Inspections and Audits

Description

Good Clinical Practice (GCP) inspections and audits are carried out to provide assurance that: the rights, safety and welfare of clinical trial subjects are protected; the data that constitute the results of the trials are accurate and reliable; and the trials are carried out in compliance with relevant legal requirements.

This module describes what investigational medicinal product sponsors, contract research organisations and clinical investigators can expect when they undergo inspection or audit. It focuses in particular on inspection by European and US regulators.

The module describes general principles of GCP inspection and audit, discusses preparation for an inspection, and sets out in detail what European and US FDA inspectors will examine. Finally it describes post-inspection actions by the regulator and the inspected party.