GCP inspection updates

Please note that the GCP inspection has updated information provided on the website. 

The updates vary in scope, but texts have been adapted to Regulation (EU) no 536/2014 and Guideline ICH E6 R3.  

A couple of texts are completely new, one of which is ‘Direct access to patient records required for monitors’ Link to text

At the bottom of each page, you will find a change log indicating whether the changes concerned reflect minor or major changes in relation to the previous content. 

The GCP inspectors may be contacted at Send en mail. 

Emails sent to this address are read and responded to as quickly as possible. We endeavour to respond to enquiries within 14 to 21 days; however, our response time may be longer for non-urgent enquiries.