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.
News and hot topics
This section includes all the latest news and information about Good Clinical Practice.
Phase 1 Accreditation Scheme
The MHRA have developed a scheme to maximise subject safety and to create additional public confidence in the regulatory oversight of such clinical trials.
The inspection process
This section outlines the Good Clinical Practice inspection process and gives details of the types of inspections and how they are carried out.
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.
Background
This page provides information about Good Clinical Practice and how the MHRA Good Clinical Practice Inspectorate works.
Serious breaches reporting
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.
Risk-based inspections
This section provides information about risk-based inspections, why the MHRA is now using this method of inspection and how they work.
Discussion forum and frequently asked questions
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.
