Reference:ICH ICH E8 Guideline R1 (2021) 4.3.3.1: Difference between revisions
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{{:Document:ICH ICH E8 Guideline R1 (2021)}} | {{:Document:ICH ICH E8 Guideline R1 (2021)}} | ||
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! | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
|- | |||
! Scope | |||
| HM | | HM | ||
|- | |- | ||
! | ! Document part | ||
| 4.3.3.1 | | 4.3.3.1 | ||
|- | |- | ||
! | ! Language | ||
| EN | | EN | ||
|- | |- | ||
! | ! Original entry by | ||
| Florian Adragna | | Florian Adragna | ||
|- | |- | ||
! | ! Contributors | ||
| | | | ||
|- | |- | ||
! | ! Tags (EN) | ||
| | | | ||
|- | |- | ||
! | ! Tags (original language) | ||
| | | | ||
|- | |- | ||
! | ! Tags (FR) | ||
| | | | ||
|- | |- | ||
! | ! Comment | ||
| Investigations in pregnant women: importance and considerations | | Investigations in pregnant women: importance and considerations | ||
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== | == Content == | ||
4.3.3.1 Investigations in pregnant women | 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. | 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. | ||
Revision as of 14:27, 29 June 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 | |
|---|---|
| Scope | HM |
| Document part | 4.3.3.1 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| 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.
