Reference:ICH ICH E8 Guideline R1 (2021) 4.3.3.1: Difference between revisions
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| | | [[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]] | ||
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Revision as of 17:29, 15 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 |
| 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.
