TABLE OF CONTENTS
I. INTRODUCTION 1
Guideline Scope 1
Guideline Structure 1
II. PRINCIPLES OF ICH GCP 2
III. ANNEX 1 7
INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC) 7
1.1 Responsibilities 7
1.2 Composition, Functions and Operations 9
1.3 Procedures 9
1.4 Records 10
1.5 Submission and Communication 11
INVESTIGATOR 11
2.1 Qualifications and Training 11
2.2 Resources 11
2.3 Responsibilities 11
2.4 Communication with IRB/IEC 12
2.5 Compliance with Protocol 12
2.6 Premature Termination or Suspension of a Trial 13
2.7 Participant Medical Care and Safety Reporting 13
2.7.1 Medical Care of Trial Participants 13
2.7.2 Safety Reporting 14
2.8 Informed Consent of Trial Participants 14
2.9 End of Participation in a Clinical Trial 18
2.10 Investigational Product Management 19
2.11 Randomisation Procedures and Unblinding 19
2.12 Records 20
2.13 Clinical Trial/Study Reports 21
3. SPONSOR 22
3.1 Trial Design 22
3.2 Resources 22
3.3 Allocation of Activities 22
3.4 Qualification and Training 22
3.4.1 Medical Expertise 22
3.5 Financing 23
3.6 Agreements 23
3.7 Investigator Selection 24
3.8 Communication with IRB/IEC and Regulatory Authority(ies) 24
3.8.1 Notification/Submission to Regulatory Authority(ies) 24
3.8.2 Confirmation of Review by IRB/IEC 25
3.9 Sponsor Oversight 25
3.10 Quality Management 26
3.10.1 Risk Management 26
3.11 Quality Assurance and Quality Control 27
3.11.1 Quality Assurance 27
3.11.2 Audit 27
3.11.3 Quality Control 28
3.11.4 Monitoring 28
3.12 Noncompliance 33
3.13 Safety Assessment and Reporting 33
3.13.1 Sponsor Review of Safety Information 34
3.13.2 Safety Reporting 34
3.13.3 Managingan Immediate Hazard 35
3.14 Insurance/Indemnification/Compensation to Participants and Investigators 35
3.15 Investigational Product(s) 35
3.15.1 Information on Investigational Product(s) 35
3.15.2 Manufacturing, Packaging, Labelling and Coding Investigational Product(s) 35
3.15.3 Supplying and Handling Investigational Product(s) 36
3.16 Data and Records 37
3.16.1 Data Handling 37
3.16.2 Statistical Programming and Data Analysis 41
3.16.3 Record Keeping and Retention 41
3.16.4 Record Access 42
3.17 Reports 42
3.17.1 Premature Termination or Suspension of a Trial 42
3.17.2 Clinical Trial/Study Reports 42
4. DATA GOVERNANCE – INVESTIGATOR AND SPONSOR 43
4.1 Safeguard Blinding in Data Governance 43
4.2 Data Life Cycle Elements 44
4.2.1 Data Capture 44
4.2.2 Relevant Metadata, Including Audit Trails 44
4.2.3 Review of Data and Metadata 45
4.2.4 Data Corrections 45
4.2.5 Data Transfer, Exchange and Migration 45
4.2.6 Finalisation of Data Sets Prior to Analysis 45
4.3 Computerised Systems 45
4.3.1 Procedures for the Use of Computerised Systems 46
4.3.2 Training 46
4.4 Security of Computerised Systems 46
4.5 Validation of Computerised Systems 46
4.6 System Failure 47
4.7 Technical Support 47
4.8 User Management 48
GLOSSARY 49
APPENDICES 58
Appendix A. INVESTIGATOR’S BROCHURE 58
A.1 Introduction 58
A.2 General Considerations 59
A.2.1 Title Page 59
A.2.2 Confidentiality Statement 59
A.3 Contents of the Investigator’s Brochure 59
A.3.1 Table of Contents 59
A.3.2 Summary 59
A.3.3 Introduction 59
A.3.4 Physical, Chemical and Pharmaceutical Properties and Formulation 59
A.3.5 Nonclinical Studies 60
A.3.6 Effects in Humans 61
A.3.7 Summary of Data and Guidance for the Investigator 62
Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
. 64
B.1 General Information 64
B.2 Background Information 64
B.3 Trial Objectives and Purpose 64
B.4 Trial Design 65
B.5 Selection of Participants 65
B.6 Withdrawal of Consent or Discontinuation of Participation 65
B.7 Treatment and Interventions for Participants 66
B.8 Assessment of Efficacy 66
B.9 Assessment of Safety 66
B.10 Statistical Considerations 66
B.11 Direct Access to Source Records 67
B.12 Quality Control and Quality Assurance 67
B.13 Ethics 67
B.14 Data Handling and Record Keeping 67
B.15 Financing and Insurance 67
B.16 Publication Policy 67
Appendix C. ESSENTIAL RECORDS FOR THE CONDUCT OF A CLINICAL TRIAL
. 68
C.1 Introduction 68
C.2 Management of Essential Records 68
C.3 Essentiality of Trial Records 69