Good Clinical Practice Guide

Invaluable resource. On my desk for reference. Already well flagged and highlighted.

The MHRA have provided a welcome tome laying the foundations to what is expected for GCP. The emphasis should remain as a guide as simply following any guidance to the letter does not in itself mean one is meeting best practice. The authors of this guide must first be complimented on the style and layout of this guideline. It serves its purpose very well. I have read the book and also dipped in at points for clarification. It is easy to read and also laid out well for reference. Since the work really follows the implementation of 2001/20EC and 2005/28/EC Directives it is perhaps a little late given the first of these directives had an implementation date of 01 May 2004 and that resulted in the loss of a star. I would have liked to have seen more information on what defines a non-interventional trial and also PASS and PACE trials. However, from personal experience of filing over 3000 clinical trials under these guidances it remains a useful reference. I strongly recommend the book to all those beginning to conduct clinical trials in the UK, Europe and the rest of the world, in addition it serves as a useful reference to those who think their method is the standard for the world.

Bought on behalf of a colleague

A very comprehensive guide illustrating the expectations of the MHRA Inspectors

Brilliant. Why did I not buy this sooner?!

good buy