ICH-E6-Guideline for Good Clinical Practice-Step4

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH Harmonised Tripartite Guideline Guideline for Good Clinical Practice E6(R1) Current Step 4 version dated 10 June 1996 (including the Post Step 4 corrections) 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. E6(R1) Document History First Codification History Date New Codification November 2005 E6 Approval by the Steering Committee under Step 2 and release for public consultation. 27April 1995 E6 E6 Approval by the Steering Committee under Step 4 and recommended for adoption to the three ICH regulatory bodies. 1 May 1996 E6         Current Step 4 version E6 Approval by the Steering Committee of Post-Step 4 editorial corrections. 10June1996 E6(R1)         Guideline for Good Clinical Practice ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 1 May 1996, this guideline is recommended for adoption to the three regulatory parties to ICH (This document includes the Post Step 4 corrections agreed by the Steering Committee on 10 June 1996) TABLE OF CONTENTS INTRODUCTION    1 1.    GLOSSARY    2 2.    THE PRINCIPLES OF ICH GCP    9 3.    INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)    9 3.1    Responsibilities    9 3.2    Composition, Functions and Operations    11 3.3    Procedures    11 3.4    Records    12 4.    INVESTIGATOR    12 4.1    Investigator's Qualifications and Agreements    12 4.2    Adequate Resources    13 4.3    Medical Care of Trial Subjects    13 4.4    Communication with IRB/IEC    13 4.5    Compliance with Protocol    14 4.6    Investigational Product(s)    14 4.7    Randomization Procedures and Unblinding    15 4.8    Informed Consent of Trial Subjects    15 4.9    Records and Reports    18 4.10    Progress Reports    19 4.11    Safety Reporting    19 4.12    Premature Termination or Suspension of a Trial    19 4.13    Final Report(s) by Investigator    20 5.    SPONSOR    20 5.1    Quality Assurance and Quality Control    20 5.2    Contract Research Organization (CRO)    20 5.3    Medical Expertise    21 5.4    Trial Design    21 5.5    Trial Management, Data Handling, and Record Keeping    21 5.6    Investigator Selection    22 5.7    Allocation of Responsibilities    23 5.8    Compensation to Subjects and Investigators    23 5.9    Financing    23 5.10    Notification/Submission to Regulatory Authority(ies)    23 5.11    Confirmation of Review by IRB/IEC    23 5.12    Information on Investigational Product(s)    24 5.13    Manufacturing, Packaging, Labelling, and Coding Investigational Product(s)    24 5.14    Supplying and Handling Investigational Product(s)    24 5.15    Record Access    25 5.16    Safety Information    25 5.17    Adverse Drug Reaction Reporting    26 5.18    Monitoring    26 5.18.1    Purpose    26 5.18.2    Selection and Qualifications of Monitors    26 5.18.3    Extent and Nature of Monitoring    26 5.18.4    Monitor's Responsibilities    27 5.18.5    Monitoring Procedures    28 5.18.6    Monitoring Report    28 5.19    Audit    29 5.19.1    Purpose    29