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 Duties and Functions 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 or Suspension of a Trial 5.22 Clinical Trial/Study Reports 5.23 Multicentre Trials
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 Duties and Functions 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 or Suspension 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:
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