A concise summary of GCP for trial pharmacists.
This book aims to help the trial pharmacist understand the GCP requirements relevant to handling study medications in a clinical trial. Following the 10 basic rules described here will facilitate compliance with the major GCP responsibilities of the investigational site in relation to product handling and accountability. The requirements in this book apply most to studies on unlicensed medicinal products, where responsibility for product accountability has been delegated to a trial pharmacist.
Author: Prof Dr David Hutchinson
Price Band: D