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The GCP Harmonization Handbook

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Description: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.We have made it easy for you to find a PDF Ebooks without any digging. And by having access to our ebooks online or by storing it on your computer, you have convenient answers with The GCP Harmonization Handbook. To get started finding The GCP Harmonization Handbook, you are right to find our website which has a comprehensive collection of manuals listed.
Our library is the biggest of these that have literally hundreds of thousands of different products represented.

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Format: PDF, EPUB & Kindle Edition

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ISBN: 1574910132

Description: 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.We have made it easy for you to find a PDF Ebooks without any digging. And by having access to our ebooks online or by storing it on your computer, you have convenient answers with The GCP Harmonization Handbook. To get started finding The GCP Harmonization Handbook, you are right to find our website which has a comprehensive collection of manuals listed.
Our library is the biggest of these that have literally hundreds of thousands of different products represented.

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The GCP Harmonization Handbook

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