ICH Harmonised Guideline for Good Clinical Practice E6(R3) - Step 4 Final

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TABLE OF CONTENTS	III
I. INTRODUCTION	1
Guideline Scope	1
Guideline Structure	1
II. PRINCIPLES OF ICH GCP	2
III. ANNEX 1 .	7
1. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC	7
1.1 Submission and Communication	8
1.2 Responsibilities	8
1.3 Composition, Functions and Operations	9
1.4 Procedures	10
1.5 Records	11
2. INVESTIGATOR	11
2.1 Qualifications and Training	11
2.2 Resources	12
2.3 Responsibilities	12
2.4 Communication with IRB/IEC	12
2.5 Compliance with Protocol	13
2.6 Premature Termination or Suspension of a Trial	14
2.7 Participant Medical Care and Safety Reporting	14
2.7.1 Medical Care of Trial Participants	14
2.7.2 Safety Reporting	14
2.8 Informed Consent of Trial Participants	15
2.9 End of Participation in a Clinical Trial	19
2.10 Investigational Product Management	20
2.11 Randomisation Procedures and Unblinding	21
2.12 Records	21
2.13 Reports	23
3. SPONSOR	23
3.1 Trial Design	23
3.2 Resources	24
3.3 Allocation of Activities	24
3.4 Qualification and Training	24
3.4.1 Medical Expertise	24
3.5 Financing	24
3.6 Agreements	24
3.7 Investigator Selection	26
3.8 Communication with IRB/IEC and Regulatory Authority(ies)	26
3.8.1 Notification/Submission to Regulatory Authority(ies)	26
3.8.2 Confirmation of Review by IRB/IEC	26
3.9 Sponsor Oversight	26
3.10 Quality Management	27
3.10.1 Risk Management	28
3.11 Quality Assurance and Quality Control	29
3.11.1 Quality Assurance	29
3.11.2 Audit	29
3.11.3 Quality Control	30
3.11.4 Monitoring	30
3.12 Noncompliance	35
3.13 Safety Assessment and Reporting	35
3.13.1 Sponsor Review of Safety Information	35
3.13.2 Safety Reporting	36
3.13.3 Managing an Immediate Hazard	36
3.14 Insurance/Indemnification/Compensation to Participants and Investigators	37
3.15 Investigational Product(s)	37
3.15.1 Information on Investigational Product(s)	37
3.15.2 Manufacturing, Packaging, Labelling and Coding Investigational Product(s)	37
3.15.3 Supplying and Handling Investigational Product(s)	38
3.16 Data and Records	39
3.16.1 Data Handling	39
3.16.2 Statistical Programming and Data Analysis	43
3.16.3 Record Keeping and Retention	43
3.16.4 Record Access	44
3.17 Reports	44
3.17.1 Premature Termination or Suspension of a Trial	44
3.17.2 Clinical Trial/Study Reports	44
4. DATA GOVERNANCE – INVESTIGATOR AND SPONSOR	45
4.1 Safeguard Blinding in Data Governance	45
4.2 Data Life Cycle Elements	46
4.2.1 Data Capture	46
4.2.2 Relevant Metadata, Including Audit Trails	46
4.2.3 Review of Data and Metadata	47
4.2.4 Data Corrections	47
4.2.5 Data Transfer, Exchange and Migration	47
4.2.6 Finalisation of Data Sets Prior to Analysis	47
4.2.7 Retention and Access	48
4.2.8 Destruction	48
4.3 Computerised Systems	48
4.3.1 Procedures for the Use of Computerised Systems	48
4.3.2 Training	48
4.3.3 Security	49
4.3.4 Validation	49
4.3.5 System Release	50
4.3.6 System Failure	50
4.3.7 Technical Support	50
4.3.8 User Management	50
APPENDICES	52
Appendix A. INVESTIGATOR’S BROCHURE	52
A.1 Introduction	52
A.2 General Considerations	53
A.2.1 Title Page	53
A.2.2 Confidentiality Statement	53
A.3 Contents of the Investigator’s Brochure	53
A.3.1 Table of Contents	53
A.3.2 Summary	53
A.3.3 Introduction	53
A.3.4 Physical, Chemical and Pharmaceutical Properties and Formulation	54
A.3.5 Nonclinical Studies	54
A.3.6 Effects in Humans	55
A.3.7 Summary of Data and Guidance	56
Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)	58
B.1 General Information	58
B.2 Background Information	58
B.3 Trial Objectives and Purpose	59
B.4 Trial Design	59
B.5 Selection of Participants	60
B.6 Discontinuation of Trial Intervention and Participant Withdrawal from Trial	60
B.7 Treatment and Interventions for Participants	60
B.8 Assessment of Efficacy	60
B.9 Assessment of Safety	61
B.10 Statistical Considerations	61
B.11 Direct Access to Source Records	61
B.12 Quality Control and Quality Assurance	62
B.13 Ethics	62
B.14 Data Handling and Record Keeping	62
B.15 Financing and Insurance	62
B.16 Publication Policy	62
Appendix C. ESSENTIAL RECORDS FOR THE CONDUCT OF A CLINICAL TRIAL	63
C.1 Introduction	63
C.2 Management of Essential Records	63
C.3 Essentiality of Trial Records	64
GLOSSARY	70

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