Table of Contents 1
Cover
2
Title Page
A Universal Guide for Implementing Good Clinical Practice
4
Preface
Goal
Scope of this Book
How to Use this Book
Opinion of the Authors
7
Part I: Good Clinical Practice History
1 History
1.1 Introduction
1.2 Objectives
1.3 Chronology
1.4 The Emergence of the ICH and Its Guidelines
1.5 Summary
References
8
Part II: Drug Development in the Regulatory Environment
2 Regulatory Environment
2.1 Introduction
2.2 Objective
2.3 Regulatory Matrix
2.4 Laws, Regulations, and Policies
2.5 Guidelines and Guidance Materials
2.6 Regulatory/Competent Authority Organizations
2.7 Academic Medical Centers (AMCs)
2.8 Professional Organizations
2.9 Summary
References
3 GCP in Context
3.1 Introduction
3.2 Objectives
3.3 Summary
Reference
4 The Intersection of GCP and Regulation
4.1 Introduction
4.2 Objectives
4.3 The Principles of ICH E6(R2)
4.4 The Definition of GCP Embodies the Full Spectrum of Trial Activity – The Definition of GCP Reads
4.5 Glossary
4.6 Combining Key Elements
4.7 Being Linked to an Organization That Is Respected and Authoritative
4.8 Standard Operating Procedures
4.9 Efficiency of Developing and Updating Materials
4.10 Value Added Practices and Principles are Adopted
4.11 Summary
Reference
5 Regulatory Affairs
5.1 Introduction
5.2 Objectives of the Chapter
5.3 Regulatory Affairs
5.4 Interacting with Regulatory/Competent Authorities
5.5 Communicating with Regulatory/Competent Authorities and Others
5.6 Meetings – When and How They fit‐GCP
5.7 Applications
5.8 Summary
References
9
Part III: Good Clinical Practice
6 GCP Definition and Principles
6.1 Introduction
6.2 Objectives
6.3 The Definition of Good Clinical Practice
6.4 Good Clinical Practice Principles
6.5 Summary
Reference
7 Players Roles and Responsibilities Overview
7.1 Introduction
7.2 Objectives
7.3 Summary
Reference
8 IRB/IEC Roles and Responsibilities
8.1 Introduction
8.2 Objectives
8.3 Responsibilities of the IRB/IEC
