Glossary:TAG-00041-Ame-run

Glossary > Amendment

Amendment
Tag-ID	TAG-00041-Ame-run
English	Amendment / Protocol amendment / Protocol modification
French	Amendement / Amendement de protocole / Modification de protocole
German	Änderung / Protokolländerung / Protokollmodifikation

References

	Scope	Document part	Language	Document
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40c-001	G	§ 40c	DE	DEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 g Absatz 3	HM	§ 63 g Absatz 3	DE	DEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.3	NIS	Leitlinie 6 6.3	DE	DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.4	NIS	2.4	DE	DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 9	G	§ 9	DE	DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 54	MD	§ 54	DE	DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 11	HM	Article 11	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 22-23	HM	Article 22-23	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 24	HM	Article 24	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 25	HM	Article 25	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
ICH ICH E6 Guideline R3 (2025) Appendix B	G	Appendix B	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Protocol Amendment	G	GLOSSARY - Protocol Amendment	EN	ICH ICH E6 Guideline R3 (2025)
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.5.1	MD	7.5.1	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
USA 21 CFR Part 312 09-Apr-2025 § 312.30	HM	§ 312.30	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.30 (b) (ii)	HM	§ 312.30 (b) (ii)	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.31	HM	§ 312.31	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 § 56.110 (b) (2)	G	§ 56.110 (b) (2)	EN	USA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.35	MD	§ 812.35	EN	USA 21 CFR Part 812 09-Apr-2025
USA 45 CFR Part 160 09-Apr-2025 § 164.526	G	§ 164.526	EN	USA 45 CFR Part 160 09-Apr-2025
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 2	HM	2	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Responsibility	HM	3.2 - Responsibility	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - Amendment	HM	4.4 - Amendment	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WMA Declaration of Helsinki 2024 Paragraph 23 - Amendment approval	G	Paragraph 23 - Amendment approval	EN	WMA Declaration of Helsinki 2024