Reference:ICH ICH E8 Guideline R1 (2021) 4.3.3.1: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:ICH ICH E8 Guideline R1 (2021) | ||
| | |module=5 | ||
| | |unit=5.4.4 | ||
| | |scope=HM | ||
| | |doc_part=4.3.3.1 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00071-Pre-nis ++ TAG-00201-Cli-eSt ++ TAG-00025-Sub-mer ++ TAG-00001-Med-rzn | |||
|tags_display=[[Glossary:TAG-00071-Pre-nis|Pregnancy]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]], [[Glossary:TAG-00025-Sub-mer|Trial participant]], [[Glossary:TAG-00001-Med-rzn|Medicinal product]] | |||
|comment=Investigations in pregnant women: importance and considerations | |||
|content=4.3.3.1 Investigations in pregnant women | |||
Investigation of drugs that may be used in pregnancy is important. Where pregnant women volunteer to be enrolled in a clinical study, or a participant becomes pregnant while participating in a clinical study, follow-up evaluation of the pregnancy and its outcome and the reporting of outcomes are necessary. | |||
}} | }} | ||
Latest revision as of 13:50, 16 July 2026
| Document information | |
|---|---|
| Reference | ICH ICH E8 Guideline R1 (2021) |
| Validity area | ICH |
| Scope(s) | HM |
| Document name | ICH E8 Guideline |
| Version / Revision | R1 (2021) |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | ICH guideline E8 (R1) on general considerations for clinical studies |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 5 — Unit 5.4.4 |
| Scope | HM |
| Document part | 4.3.3.1 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Pregnancy, Clinical investigation, Trial participant, Medicinal product |
Content
4.3.3.1 Investigations in pregnant women Investigation of drugs that may be used in pregnancy is important. Where pregnant women volunteer to be enrolled in a clinical study, or a participant becomes pregnant while participating in a clinical study, follow-up evaluation of the pregnancy and its outcome and the reporting of outcomes are necessary.
