Reference:ICH ICH E6 Guideline R3 (2025) I: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:ICH ICH E6 Guideline R3 (2025) | ||
| | |module=1 | ||
| | |unit=1.1.4 | ||
| | |scope=G | ||
| | |doc_part=I | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00043-Goo-tek ++ TAG-00318-Fun-nzi ++ TAG-00051-Eth-ngs | |||
|tags_display=[[Glossary:TAG-00043-Goo-tek|Good clinical practice]], [[Glossary:TAG-00318-Fun-nzi|Fundamentals]], [[Glossary:TAG-00051-Eth-ngs|Ethics]] | |||
|comment=Foundations of GCP | |||
|content=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. | |||
}} | }} | ||
Revision as of 12:54, 16 July 2026
| 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 | |
|---|---|
| Module | Module 1 — Unit 1.1.4 |
| Scope | G |
| Document part | I |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Good clinical practice, Fundamentals, Ethics |
Content
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.
