ICH E6 (R2) Good clinical practice

Current effective version

PDF iconRevision 2 - Adopted guideline

Reference numberEMA/CHMP/ICH/135/1995
Effective from14/06/2017
KeywordsGood clinical practice (GCP), Ethics Committee, Institutional Review Board, investigator, sponsor, protocol, investigator's brochure, trial design, safety reporting, informed consent, statistics, clinical study/trial report
DescriptionThis 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.

Document history

Revision 2

Current version

PDF iconAdopted guideline

PDF iconDraft guideline

Published: 15/12/2016

Effective from: 14/06/2017

Published: 04/08/2015

Revision 1

PDF iconAdopted guideline

Published: 01/07/2002

In operation: 01/01/1997-14/06/2017

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