HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) …

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HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE

(GCP)

GUIDANCE FOR

IMPLEMENTATION

WHO Library Cataloguing-in-Publication Data Handbook for good clinical research practice (GCP): Guidance for implementation ISBN

The World Health Organization welcomes requests for permission to reproduce or translate its publications, in part or in full. Applications and enquiries should be addressed to the Office of Publications, World Health Organization, Geneva, Switzerland, which will be glad to provide the latest information on any changes made to the text, plans for new editions, and reprints and translations already available. ? World Health Organization 2002 Publications of the World Health Organization enjoy copyright protection in accordance with the provisions of Protocol 2 of the Universal Copyright Convention. All rights reserved. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the Secretariat of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. The mention of specific companies or of certain manufacturers' products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. Designed by minimum graphics Printed in

Contents

Preamble

1

Introduction

3

Overview of the Clinical Research Process

8

WHO Principles of GCP

21

Principle 1: Ethical Conduct

21

Principle 2: Protocol

27

Principle 3: Risk Identification

35

Principle 4: Benefit-Risk Assessment

42

Principle 5: Review by Independent Ethics Committee/

Independent Review Board

48

Principle 6: Protocol Compliance

54

Principle 7: Informed Consent

59

Principle 8: Continuing Review/Ongoing Benefit-Risk

Assessment

72

Principle 9: Investigator Qualifications

82

Principle 10: Staff Qualifications

87

Principle 11: Records

92

Principle 12: Confidentiality/Privacy

103

Principle 13: Good Manufacturing Practice

110

Principle 14: Quality Systems

115

References:

121

Documents on CD

121

Other documents cited in the Handbook

122

Related documents

123

National Good Clinical Practice and Other Guidelines

124

Acknowledgements

125

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Preamble

Clinical research is necessary to establish the safety and effectiveness of specific health and medical products and practices. Much of what is known today about the safety and efficacy of specific products and treatments has come from randomized controlled clinical trials1 that are designed to answer important scientific and health care questions. Randomized controlled trials form the foundation for "evidence-based medicine", but such research can be relied upon only if it is conducted according to principles and standards collectively referred to as "Good Clinical Research Practice" (GCP). This handbook is issued as an adjunct to WHO's "Guidelines for good clinical practice (GCP) for trials on pharmaceutical products" (1995), and is intended to assist national regulatory authorities, sponsors, investigators and ethics committees in implementing GCP for industrysponsored, government-sponsored, institution-sponsored, or investigator-initiated clinical research. The handbook is based on major international guidelines, including GCP guidelines issued subsequent to 1995, such as the International Conference on Harmonization (ICH) Good Clinical Practice: Consolidated Guideline and is organized as a reference and educational tool to facilitate understanding and implementation of GCP by: ? describing the clinical research process as it relates to health and

medical products, and identifying and explaining each of the activities that are common to most trials and the parties who are ordinarily responsible for carrying them out; ? linking each of these processes to one or more Principle(s) of GCP within this Handbook;

1 These trials assign trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.

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