ICH Harmonised Guideline - Good Clinical Practice (GCP) - E6(R3) - Draft version - Endorsed on 19 May 2023

Oct 2, 2026

Uploaded by jayni

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) publishes the E6(R3) ICH Harmonised Guideline for Good Clinical Practice (GCP). The draft version is currently under public consultation at Step 2 of the ICH Process, following expert working group consensus and transmission to ICH region regulatory authorities for internal and external review. The document includes a legal notice on copyright and permitted use, and provides a structured table of contents covering introduction, principles, and annex sections on IRB/IEC and investigator responsibilities.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages79

Reading Time3 h 19 min

AccessFree to download

I. INTRODUCTION

Guideline Scope

Guideline Structure

II. PRINCIPLES OF ICH GCP

III. ANNEX 1

1. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)

2. INVESTIGATOR

INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE GOOD CLINICAL PRACTICE (GCP) E6(R3) Draft version Endorsed on 19 May 2023 Currently under public consultation At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the regulatory authorities of the ICH regions for internal and external consultation, according to national or regional procedures. E6(R3) Document History | Code | History | Date | | --- | --- | --- | | E6 | Approval by the Steering Committee under Step 2 and release for public consultation. | 27 April 1995 | | E6 | Approval by the Steering Committee under Step 4 and recommended for adoption to the three ICH regulatory bodies. | 1 May 1996 | | E6(R1) | Approval by the Steering Committee of Post-Step 4 editorial corrections. | 10 June 1996 | | E6(R2) | Adoption by the Regulatory Members of the ICH Assembly under Step 4. Integrated Addendum to ICH E6(R1) document. Changes are integrated directly into the following sections of the parental Guideline: Introduction, 1.63, 1.64, 1.65, 2. 10, 2. 13, 4.2.5, 4.2.6, 4.9.0, 5.0, 5.0. 1, 5.0.2, 5.0.3, 5.0.4, 5.0.5, 5.0.6, 5.0.7, 5.2.2, 5.5.3 (a), 5.5.3 (b), 5.5.3 (h), 5.18.3, 5.18.6 (e), 5.18.7, 5.20.1, 8.1 | 9 November 2016 | | E6(R3) | Endorsement by the Members of the ICH Assembly under Step 2 and release for public consultation. | 19 May 2023 | Legal notice: This document is protected by copyright and may, with the exception of the ICH logo, be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that ICH's copyright in the document is acknowledged at all times. In case of any adaption, modification or translation of the document, reasonable steps must be taken to clearly label, demarcate or otherwise identify that changes were made to or based on the original document. Any impression that the adaption, modification or translation of the original document is endorsed or sponsored by the ICH must be avoided. The document is provided "as is" without warranty of any kind. In no eventshall the ICH or the authors of the original document be liable for any claim, damages or other liability arising from the use of the document. The above-mentioned permissions do not apply to content supplied by third parties. Therefore, for documents where the copyright vests in a third party, permission for reproduction must be obtained from this copyright holder. ICH HARMONISED GUIDELINE GOOD CLINICAL PRACTICE (GCP) E6(R3) ICH Consensus Guideline TABLE OF CONTENTS 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 Responsibilities .............................................................................................................7 1.2 Composition, Functions and Operations ...................................................................9 1.3 Procedures .................................................................................................................... 9 1.4 Records...................................

FAQs

What is the status of ICH E6(R3) and where is it in the ICH process?

E6(R3) is a draft version currently under public consultation at Step 2 of the ICH Process.

How is a consensus draft guideline transmitted for review?

After consensus by the appropriate ICH Expert Working Group, the draft text is transmitted by the ICH Assembly to regulatory authorities of ICH regions for internal and external consultation according to national or regional procedures.

What is the scope of topics covered by the table of contents?

The table of contents includes the introduction, principles of ICH GCP, and Annex 1 sections covering IRB/IEC and investigator responsibilities, procedures, records, and related clinical trial governance topics.

Oct 2, 2026

Uploaded by jayni