Glossary:TAG-00329-Saf-lne

Glossary > Safety

Safety
Tag-ID	TAG-00329-Saf-lne
English	Safety / Patient safety / Subject safety / Trial safety
French	Sécurité / Sécurité des patients / Sécurité des participants / Sécurité de l'essai
German	Sicherheit / Patientensicherheit / Teilnehmersicherheit / Prüfungssicherheit

References

	Scope	Document part	Language	Document
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 11	NIS	Leitlinie 11	DE	DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018
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 Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 3	MD	Article 62 Paragraph 3	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 3 & 4	MD	Article 62 Paragraph 3 & 4	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 82	MD	Article 82	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 53	HM	Article 53	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (b)-001	HM	Article 10 (b)	EN	GBR Directive 2001/20/EC 04-Apr-2001
GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (b)-002	HM	Article 10 (b)	EN	GBR Directive 2001/20/EC 04-Apr-2001
ICH ICH E2A Guideline 1994 III A. 2.	G	III A. 2.	EN	ICH ICH E2A Guideline 1994
ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.4 - 2.5	G	Annex 2 2.4 - 2.5	EN	ICH ICH E6 Guideline - Annex 2 R3 Annex 2
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.2 (a)	G	III. Annex 1 2.7.2 (a)	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.2 (a) - (d)	G	III. Annex 1 2.7.2 (a) - (d)	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.1	G	III. Annex 1 3.13.1	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.2 (a) - (b) ; (d) - (f)	G	III. Annex 1 3.13.2 (a) - (b) ; (d) - (f)	EN	ICH ICH E6 Guideline R3 (2025)
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.5	MD	9.2.5	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
USA 21 CFR Part 312 09-Apr-2025 § 312.3 - IEC	HM	§ 312.3 - IEC	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.32 (b)	HM	§ 312.32 (b)	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.32 (d)	HM	§ 312.32 (d)	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.42	HM	§ 312.42	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.60-001	HM	§ 312.60	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.60-002	HM	§ 312.60	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 Subpart E	MD	Subpart E	EN	USA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.100	MD	§ 812.100	EN	USA 21 CFR Part 812 09-Apr-2025
USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. B.	G	III. B.	EN	USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - ethics committee	HM	Glossary - ethics committee	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995