The MHRA's Good Clinical Practice (GCP) Inspectorate is part of the Inspection, Standards and Enforcement Division of the MHRA. It assesses the compliance of organisations conducting clinical trials using investigational medicinal products with UK and EU legislation.
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Good Clinical Practice Guide
The ‘Good Clinical Practice Guide’ is a brand new publication covering the legislation, guidance and good practice that relates to the conduct of clinical trials of medicinal products for human use in the UK.
We have issued guidance on the notification of serious breaches of GCP. This guidance outlines the practical arrangements for notifications and provides advice on what should and what should not be classified as a “serious breach” and what must be reported.
The GCP forum has been created as a tool to help those involved in clinical trials of Investigational Medicinal Products to comply with the clinical trials legislation and GCP requirements and provides the ideal opportunity for extended communication between researchers. It also provides answers to frequently asked questions relating to GCP.