The GCP Harmonization Handbook

This book is designed to present those involved in clinical research with the similarities and the important differences between the GCP regulations of the United States, European Union, Japan, Australia, and Canada, as well as draft documents issued by the ICH and the FDA. Section 1 presents a side-by-side comparison of the tables of contents of six different GCPs, allowing instant recognition and understanding of the similarities and differences among them in organization and scope. Three comparative tables organize the data in different, useful ways. Section 2 contains the actual texts of the six GCPs, organized into sixteen subject areas: Scope, Definitions, Informed Consent, Institutional Review Boards (IRBs) and Ethics Committees, Protocols and Statistics, Adverse Findings, Administrative Actions, Sponsor Responsibilities, Recordkeeping, Inspections, Quality Assurance, Investigational Drug Supplies, Investigator Responsibilities, Ethical Principles, Clinical Study Reports, and other related topics and resources. Section 3 includes verbatim texts of the six GCP regulations in their original orders. Section 4 comprises a glossary based on the GCP texts.