Essential GCP Book

Essential GCP Book
Product Code: Essential GCP Book
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by Prof David Hutchinson

Good Clinical Practice (GCP) is an international quality standard. In order for clinical trials on medicinal products in humans to achieve international recognition, they should be conducted in accordance with GCP. In many countries this is a legal requirement, as GCP principles have been incorporated into national laws. Adherence to GCP is also a requirement for publication in many international medical journals. Any reputable clinical trial should therefore be compliant with GCP.

This book is based on the GCP guidelines developed by the International Conference on Harmonisation (ICH E6 (R2)). The guidelines (ICH GCP) have become a proven international standard that is globally recognised and is the guidance of choice for both commercial and non-commercial trials.

This is an essential guide to GCP for sponsors and investigators contains information in an easy to read format, with questions to consolidate knowledge and an answer section (60 pages, perfect bound paperback):
•Introduction to good clinical practice
•Factors affecting clinical trials
•GCP development
•Principles of GCP
•Compliance with GCP
•Documenting GCP compliance
•The investigator and study site
•Addressing the risks of trials
•Management of investigational medicinal product
•The study protocol
•Recruiting trial subjects
•Subject protection
•Data collection in clinical trials
•Safety monitoring, recording and reporting
•Analysis and reporting of trial data
•End of study procedures
•GCP compliance and inspections
•Due diligence is the key
•Essential study documentation
•Computerised systems
•Checklists of trial documents



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