How to prepare for an inspection for Good Clinical Practice

This guidance is primarily for NHS organisations, to help them prepare for statutory inspection by the Medicines and Healthcare products Regulatory Agency (MHRA) in relation to the conduct of Clinical Trials of Medicinal Products. This guidance updates the previous document dated 31 Oct 2006 and incorporates feedback from a sample of NHS Trusts who have been inspected during 2006/7. Also the MHRA has published guidance to give assistance to sponsors formulating the response to their MHRA inspection report to ensure that this post-inspection activity is handled as efficiently as possible. The update does not significantly affect the guidance and is presented, for your convenience, at
Appendix I.
This document provides guidance on:
• The obligations on an NHS Trust when hosting or sponsoring CTIMPs;
• What an MHRA inspection is;
• How to prepare for an MHRA inspection;
• What it is like to be inspected by the MHRA; and
• Common findings from inspections conducted by the MHRA.
The appendices provide:
• A list of key definitions;
• A series of directed weblinks where readers can access further information;
• Assistance in deciding if a project is a CTIMP;
• Checklists of documents required for the conduct of a CTIMP;
• Example MHRA notification letter to an NHS organisation;
• Example internal letters to researchers;
• Examples of MHRA inspection plans; and
• Information on who helped prepare this report;