The highly regulated world we operate in as clinical researchers means we must be ready for audit and inspection at any time. The MHRA is the competent authority in the UK who oversees the licensing of new drugs and the conduct of clinical trials of both drugs and devices. As part of their statutory remit they conduct compulsory inspections of sites and institutions on a regular basis. One important aspect of these inspections is ensuring that a study is being conducted in compliance with the legislation and in accordance with the Principles of GCP.

Thus, being prepared for a GCP inspection is an essential part of good research conduct. In this workshop, Allan Gaw, will take delegates through the elements of a GCP inspection, and, using a mixture of short lecture presentations and practical activities, will help them develop an effective strategy for preparing for such a visit.