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)
ICH guideline for good clinical practice E6(R2) - Step 5
Adopted Legal effective date: 01/01/1997 Reference Number: EMA/CHMP/ICH/135/1995English (EN) (693.2 KB - PDF)
First published: 01/07/2002 Last updated: 15/12/2016Draft ICH E6 (R3) Guideline on good clinical practice (GCP) - Step 2b
Consultation dates: 26/05/2023 to 26/09/2023 Draft: consultation closed Reference Number: EMA/CHMP/ICH/135/1995
English (EN) (774.37 KB - PDF)
First published: 26/05/2023Overview of comments on ICH E6 (R3) guideline
Reference Number: EMA/553381/2023 Rev.1English (EN) (1.72 MB - PDF)
First published: 19/12/2023 Last updated: 22/12/2023ICH guideline for good clinical practice E6(R2) - Step 5
Adopted Legal effective date: 01/01/1997 Reference Number: EMA/CHMP/ICH/135/1995English (EN) (693.2 KB - PDF)