Glossary:TAG-00071-Pre-nis

Glossary > Pregnancy

Pregnancy
Tag-ID	TAG-00071-Pre-nis
English	Pregnancy / Pregnancy in clinical trials / Pregnancy outcome
French	Grossesse / Grossesse dans les essais cliniques / Issue de grossesse
German	Schwangerschaft / Schwangerschaft in klinischen Prüfungen / Schwangerschaftsausgang

References

	Scope	Document part	Language	Document
CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 18	G	GUIDELINE 18	EN	CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016
CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 19	G	GUIDELINE 19	EN	CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016
EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005 2.1	HM	2.1	EN	EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 66	MD	Article 66	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX III Section 2.1	HM	ANNEX III Section 2.1	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 33	HM	Article 33	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
ICH ICH E21 Concept paper 2023 2.	G	2.	EN	ICH ICH E21 Concept paper 2023
ICH ICH E8 Guideline R1 (2021) 4.3.3.1	HM	4.3.3.1	EN	ICH ICH E8 Guideline R1 (2021)
USA 45 CFR Part 46 09-Apr-2025 Subpart B	G	Subpart B	EN	USA 45 CFR Part 46 09-Apr-2025
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.6.6.1	G	5.6.6.1	EN	USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024
WHO WHO - Guidance for best practices for clinical trials 2024 2.1.3	G	2.1.3	EN	WHO WHO - Guidance for best practices for clinical trials 2024