The Fundamentals of Clinical Research. P. Michael Dubinsky

      

      Table of Contents

      1  Cover

      2  Title Page A Universal Guide for Implementing Good Clinical Practice

      3  Copyright Page

      4  Preface Goal Scope of this Book How to Use this Book Opinion of the Authors

      5  About the Authors

      6  About 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