Good Clinical Practice (GCP ICH USA-EUROPA-JAPÃO) 1997 (versão em ingles)

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

ICH HARMONISED TRIPARTITE GUIDELINE

GUIDELINE FOR GOOD CLINICAL PRACTICE

Recommended for Adoption

at Step 4 of the ICH Process

on 1 May 1996

by the ICH Steering Committee

This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.

TABLE OF CONTENTS

INTRODUCTION

1. GLOSSARY

2. THE PRINCIPLES OF ICH GCP

3. INSTITUTIONAL REVIEW BOARD / INDEPENDENT ETHICS COMMITTEE (IRB/IEC)

3.1 Responsibilities 3.2 Composition, Functions and Operations 3.3 Procedures 3.4 Records

4. INVESTIGATOR

4.1 Investigator's Qualifications and Agreements 4.2 Adequate Resources 4.3 Medical Care of Trial Subjects 4.4 Communication with IRB/IEC 4.5 Compliance with Protocol 4.6 Investigational Product(s) 4.7 Randomization Procedures and Unblinding 4.8 Informed Consent of Trial Subjects 4.9 Records and Reports 4.10 Progress Reports 4.11 Safety Reporting 4.12 Premature Termination or Suspension of a Trial 4.13 Final Report(s) by Investigator

5. SPONSOR

5.1 Quality Assurance and Quality Control 5.2 Contract Research Organization (CRO) 5.3 Medical Expertise 5.4 Trial Design 5.5 Trial Management, Data Handling, and Record Keeping 5.6 Investigator Selection 5.7 Allocation of Responsibilities 5.8 Compensation to Subjects and Investigators 5.9 Financing 5.10 Notification/Submission to Regulatory Authority(ies) 5.11 Confirmation of Review by IRB/IEC 5.12 Information on Investigational Product(s) 5.13 Manufacturing, Packaging, Labelling, and Coding Investigational Product(s) 5.14 Supplying and Handling Investigational Product(s) 5.15 Record Access 5.16 Safety Information 5.17 Adverse Drug Reaction Reporting 5.18 Monitoring 5.18.1 Purpose 5.18.2 Selection and Qualifications of Monitors 5.18.3 Extent and Nature of Monitoring 5.18.4 Monitor's Responsibilities 5.18.5 Monitoring Procedures 5.18.6 Monitoring Report 5.19 Audit 5.19.1 Purpose 5.19.2 Selection and Qualification of Auditors 5.19.3 Auditing Procedures 5.20 Noncompliance 5.21 Premature Termination of a Trial 5.22 Clinical Trial/Study Reports 5.23 Multicentre Trials

6. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)

6.1 General Information 6.2 Background Information 6.3 Trial Objectives and Purpose 6.4 Trial Design 6.5 Selection and Withdrawal of Subjects 6.6 Treatment of Subjects 6.7 Assessment of Efficacy 6.8 Assessment of Safety 6.9 Statistics 6.10 Direct Access to Source Data/Documents 6.11 Quality Control and Quality Assurance Procedures 6.12 Ethics 6.13 Data Handling and Record Keeping 6.14 Financing and Insurance 6.15 Publication Policy 6.16 Supplements

7. INVESTIGATOR'S BROCHURE

7.1 Introduction 7.2 General Considerations 7.2.1 Title Page 7.2.2 Confidentiality Statement 7.3 Contents of the Investigator's Brochure 7.3.1 Table of Contents 7.3.2 Summary 7.3.3 Introduction 7.3.4 Physical, Chemical, and Pharmaceutical Properties and Formulation 7.3.5 Nonclinical Studies 7.3.6 Effects in Humans 7.3.7 Summary of Data and Guidance for the Investigator 7.4 Appendix 1 7.5 Appendix 2

8. ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL

8.1 Introduction 8.2 Before the Clinical Phase of the Trial Commences 8.3 During the Clinical Conduct of the Trial 8.4 After Completion or Termination of the Trial

GUIDELINE FOR GOOD CLINICAL PRACTICE

INTRODUCTION

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

The guideline was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organization (WHO). This guideline should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities. The principles established in this guideline may also be applied to other clinical investigations that may have an impact on the safety and well-being of human subjects.