Glossary:TAG-00176-Ris-erh

Risk
Tag-ID	TAG-00176-Ris-erh
English	Risk / Safety risk
French	Risque / Risque pour la sécurité
German	Risiko / Sicherheitsrisiko

References

	Scope	Document part	Language	Document
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.6	G	4.6	EN	EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023
EU European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 45838 -	G	-	EN	EU European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 45838
EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 2.	HM	2.	EN	EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017
EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.1	HM	4.1	EN	EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017
USA 21 CFR Part 312 09-Apr-2025 § 312.56	HM	§ 312.56	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 50 09-Apr-2025 § 50.3 (k)-002	G	§ 50.3 (k)	EN	USA 21 CFR Part 50 09-Apr-2025
WMA Declaration of Helsinki 2024 Paragraph 17	G	Paragraph 17	EN	WMA Declaration of Helsinki 2024

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