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Reference:ICH ICH E6 Guideline R3 (2025) I: Difference between revisions

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Document Information

Document information
Reference ICH ICH E6 Guideline R3 (2025)
Validity area ICH
Scope(s) HM
Document name ICH E6 Guideline
Version / Revision R3 (2025)
Status Current
Document type International guideline
Language(s) EN
Description GUIDELINE FOR GOOD CLINICAL PRACTICE
Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors


Reference Details

Scope G
Document part I
Language EN
Original entry by Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment Foundations of GCP

Text

Good Clinical Practice (GCP) is an international, ethical, scientific and quality standard for the conduct of trials that involve human participants. Clinical trials conducted in accordance with this standard will help to assure that the rights, safety and well-being of trial participants are protected; that the conduct is consistent with the principles that have their origin in the Declaration of Helsinki; and that the clinical trial results are reliable.