View source for Reference:ICH ICH E8 Guideline R1 (2021) 4.3.3.1

{{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.
}}