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P. Michael Dubinsky
The Fundamentals of Clinical Research
Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 1
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Вернуться на страницу книги The Fundamentals of Clinical Research
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Страница 1
Table of Contents
List of Tables
List of Illustrations
Guide
Pages
The Fundamentals of Clinical Research A Universal Guide for Implementing Good Clinical Practice
Страница 8
Страница 9
About the Authors
About the Authors
Страница 12
1 History
GCP Key Point
1.1 Introduction
1.2 Objectives
1.3 Chronology
1.4 The Emergence of the ICH and Its Guidelines
1.5 Summary
Knowledge Check Questions
References
Страница 22
2 Regulatory Environment
GCP Key Point
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
Knowledge Check Questions
References
3 GCP in Context
GCP Key Point
3.1 Introduction
3.2 Objectives
3.2.1 Discovery
3.2.2 1.4 Pre‐Clinical Studies
3.2.3 Clinical Studies
3.2.4 Manufacturing the Investigational Drug Product
3.2.5 Common Properties of GXPs
3.3 Summary
Knowledge Check Questions
Reference
4 The Intersection of GCP and Regulation
GCP Key Point
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 4.4.1 Good Clinical Practice (GCP)
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
Knowledge Check Questions
Reference
5 Regulatory Affairs
GCP Key Point
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
Knowledge Check Questions
References
Страница 75
6 GCP Definition and Principles
GCP Key Point
6.1 Introduction
6.2 Objectives
6.3 The Definition of Good Clinical Practice
6.4 Good Clinical Practice Principles
6.5 Summary
Knowledge Check Questions
Reference
7 Players Roles and Responsibilities Overview
GCP Key Point
7.1 Introduction
7.2 Objectives
7.2.1 Main Players Involved in the Conduct of a Clinical Trial
7.2.1.1 The Sponsor
7.2.1.2 The Investigator
7.2.1.3 The Subject/Trial Subject
7.2.1.4 The IRB/IEC
7.2.1.5 The Regulatory Authority
7.2.2 How the Main Players Interact
7.3 Summary
Knowledge Check Questions
Reference
Страница 99
9 Investigator and Sponsor Roles and Responsibilities
GCP Key Point
9.1 Introduction
9.2 Objectives
9.2.1 Definitions
9.2.2 Sponsor and Investigator Responsibilities in the Context of the Clinical Trial Process
9.2.2.1 Before the Clinical Phase of the Trial Commences
9.2.2.1.1 The Sponsor
9.2.2.1.2 The Investigator
9.2.2.1.3 The Sponsor
9.2.2.2 During the Clinical Conduct of the Trial
9.2.2.2.1 The Investigator
9.2.2.2.2 The Sponsor
9.2.2.3 After Completion or Termination of the Trial
9.2.2.3.1 The Investigator
9.2.2.3.2 The Sponsor
9.2.2.3.3 The Sponsor and Investigator
9.3 Summary
Knowledge Check Questions
References
10 The Research Volunteer
GCP Key Point
10.1 Introduction
10.2 Objectives
10.2.1 The Definition and Role of Trial Subject
10.2.2 Voluntary Responsibilities of a Trial Subject
10.2.2.1 Voluntary Responsibilities for Protection of Rights, Safety, and Well‐being
10.2.2.1.1 Prior to Volunteering for a Clinical Trial
10.2.2.1.2 Volunteering to Participate in the Trial
10.2.2.1.3 Participating in the Trial
10.2.2.2 Voluntary Responsibilities for Data Integrity
10.2.2.3 Voluntary Responsibilities for Trial Compliance
10.2.3 Quality by Design Considerations to Facilitate Subject Compliance with Trial Requirements
10.3 Summary
Knowledge Check Questions
Reference
11 Regulatory Authority – Roles and Responsibilities
GCP Key Point
11.1 Introduction
11.2 Objectives
11.3 Definition and Overview
11.4 Trial Approval – Submission of Applications
11.5 Communication, Reporting, and Oversight
11.6 Inspections and Oversight
11.7 Summary
Knowledge Check Questions
Страница 143
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