Guideline for good clinical practice

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 toconsultation 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
New Codification November 2005 E6 E6

First Codification E6 E6

History

Date

Approval by the Steering Committee under Step 2 and release for publicconsultation. Approval by the Steering Committee under Step 4 and recommended for adoption to the three ICH regulatory bodies.

27 April 1995 1 May 1996

Current Step 4 version
E6 Approval by the Steering Committee of Post-Step 4 editorial corrections. 10 June 1996 E6(R1)

GUIDELINE FOR GOOD CLINICAL PRACTICE
ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process atthe 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. 2. 3. 3.1 3.23.3 3.4 4. 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 GLOSSARY .............................................................................................................2 THE PRINCIPLES OF ICH GCP........................................................................8 INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE(IRB/IEC).......................................................................................9 Responsibilities.........................................................................................................9 Composition, Functions and Operations...............................................................11 Procedures ..............................................................................................................11Records....................................................................................................................12 INVESTIGATOR ..................................................................................................12 Investigator's Qualifications and Agreements......................................................12 Adequate Resources...............................................................................................12 Medical Care of Trial Subjects...............................................................................13 Communication with IRB/IEC...............................................................................13 Compliance with Protocol ......................................................................................13 InvestigationalProduct(s)......................................................................................14 Randomization Procedures and Unblinding .........................................................15 Informed Consent of Trial Subjects.......................................................................15 Records andReports...............................................................................................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...