A second edition (November 2017) of Prof David Hutchinson’s popular book describing the basics of good clinical practice. Revised in the light of the changes to ICH GCP with a new section on risk based approaches.
This book is based on the GCP guidelines developed by the ICH GCP guidelines E6(R2). It is suitable for anyone needing a basic understanding of GCP. (70+ pages, perfect bound paperback)
Content includes: 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 - Product accountability - 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 - Computerized systems - Checklists of trial documents - The sponsors’ quality management system - Risk-based approach to trial monitoring
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