This book by Prof David Hutchinson is an overview of the requirements laid down by the ICH GCP E6(R2) guidelines. This is an essential guide to GCP for sponsors and investigators. It provides information and practical advice in an easy-to-read format, with a question and answer section to consolidate knowledge. This is a must for novices to clinical research and is also a good recap for the more experienced monitors, auditors and investigators.
Author: Prof Dr David Hutchinson