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Glossary:TAG-00071-Pre-nis

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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 PrĂźfungen / Schwangerschaftsausgang

References

 ScopeDocument partLanguageDocument
CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 18GGUIDELINE 18ENCIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016
CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 19GGUIDELINE 19ENCIOMS 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 2.1HM2.1ENEU 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 66MDArticle 66ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX III Section 2.1HMANNEX III Section 2.1ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 33HMArticle 33ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
ICH ICH E21 Concept paper 2023 2.G2.ENICH ICH E21 Concept paper 2023
ICH ICH E8 Guideline R1 (2021) 4.3.3.1HM4.3.3.1ENICH ICH E8 Guideline R1 (2021)
USA 45 CFR Part 46 09-Apr-2025 Subpart BGSubpart BENUSA 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 5.6.6.1G5.6.6.1ENUSA 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 2.1.3G2.1.3ENWHO WHO - Guidance for best practices for clinical trials 2024
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