Glossary:TAG-00068-Dev-gsb

Glossary > DSUR

DSUR
Tag-ID	TAG-00068-Dev-gsb
English	Development safety update report
EN Abbr.	DSUR
French	Rapport périodique de mise à jour de la sécurité / Rapport de sécurité pour le développement
FR Abbr.	DSUR / RPMS
German	Entwicklungssicherheitsaktualisierungsbericht / Entwicklungs-Sicherheitsbericht
DE Abbr.	DSUR

References

	Scope	Document part	Language	Document
AUT Question - BASG 11-Feb-2025 -	G	-	DE	AUT Question - BASG 11-Feb-2025
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 43	HM	Article 43	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 3.	MD	3.	FR	FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 35	HM	Article 35	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
ICH ICH E2F Guideline 2010 1	G	1	EN	ICH ICH E2F Guideline 2010
USA 21 CFR Part 312 09-Apr-2025 § 312.33 (a) - (b)	HM	§ 312.33 (a) - (b)	EN	USA 21 CFR Part 312 09-Apr-2025
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.4	G	1.4	EN	USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024