ICH E6 (R2) Good clinical practice - Scientific guideline
Table of contents
This document addresses the good clinical practice, an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. It aims to provide a unified standard for the ICH regions to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
Keywords: Good clinical practice (GCP), Ethics Committee, investigator, sponsor, protocol, investigator's brochure, trial design, safety reporting, informed consent, statistics, clinical study/trial report, clinical trials, innovation, design, ICH E6(R3)
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Draft ICH E6 (R3) Guideline on good clinical practice (GCP) - Step 2b (PDF/774.37 KB)
Draft: consultation closed
First published: 26/05/2023
Consultation dates: 26/05/2023 to 26/09/2023
EMA/CHMP/ICH/135/1995 -
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Template for submission of comments on ICH E6 (R3) guideline (XLSX/207.09 KB)
First published: 26/05/2023
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ICH guideline for good clinical practice E6(R2) - Step 5 (PDF/693.2 KB)
Adopted
First published: 01/07/2002
Last updated: 15/12/2016
Legal effective date: 01/01/1997
EMA/CHMP/ICH/135/1995 -
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Draft ICH guideline E6 on good clinical practice (PDF/359.02 KB)
Draft
First published: 24/06/2021
EMA/CHMP/ICH/337843/2021
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ICH guideline for good clinical practice E6(R2) 4 - Step 2b (PDF/681.68 KB)
Draft: consultation closed
First published: 04/08/2015
Last updated: 04/08/2015
Consultation dates: 04/08/2015 to 03/02/2016
EMA/CHMP/ICH/135/1995 -
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ICH E6 (R1) guideline for Good Clinical Practice (PDF/398.19 KB)
Adopted
First published: 01/07/2002
Last updated: 01/07/2002
CPMP/ICH/135/95