Reference:ICH ICH E6 Guideline R3 (2025) II 2.4: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:ICH ICH E6 Guideline R3 (2025) | ||
| | |module=3 | ||
| | |unit=3.1.4 | ||
|scope=G | |||
|doc_part=II | |||
2.4 | 2.4 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
| | |tags=TAG-00029-Inf-rte ++ TAG-00028-Leg-ich ++ TAG-00069-Imm-rhe | ||
|tags_display=[[Glossary:TAG-00029-Inf-rte|Informed consent]], [[Glossary:TAG-00028-Leg-ich|Legal representative]], [[Glossary:TAG-00069-Imm-rhe|Urgent safety measure]] | |||
|comment=Emergency consent: deferred consent provisions | |||
|content=2.4 In emergency situations, where consent cannot be obtained prior to trial participation, consent should be obtained from the participant or their legally acceptable representative as soon as possible in accordance with applicable regulatory requirements and the processes approved by the institutional review board/independent ethics committee (IRB/IEC). | |||
}} | }} | ||
Latest revision as of 13:49, 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 3 — Unit 3.1.4 |
| Scope | G |
| Document part | II
2.4 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Informed consent, Legal representative, Urgent safety measure |
Content
2.4 In emergency situations, where consent cannot be obtained prior to trial participation, consent should be obtained from the participant or their legally acceptable representative as soon as possible in accordance with applicable regulatory requirements and the processes approved by the institutional review board/independent ethics committee (IRB/IEC).
