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)

Current version

ICH guideline for good clinical practice E6(R2) - Step 5

Revision 3

Draft ICH E6 (R3) Guideline on good clinical practice (GCP) - Step 2b

Overview of comments on ICH E6 (R3) guideline

Revision 2

ICH guideline for good clinical practice E6(R2) - Step 5

Draft ICH guideline E6 on good clinical practice

Revision 1

ICH guideline for good clinical practice E6(R2) 4 - Step 2b

ICH E6 (R1) guideline for Good Clinical Practice

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