Glossary:TAG-00274-Fin-Spo

Glossary > Sponsor final report

Sponsor final report
Tag-ID	TAG-00274-Fin-Spo
English	Final report sponsor to authority / Sponsor final report / Clinical study report submission / Study results submission to authority
French	Rapport final du promoteur à l'autorité / Rapport de l'étude clinique du promoteur / Soumission du rapport final
German	Abschlussbericht des Sponsors an die Behörde / Sponsor-Abschlussbericht / Ergebniseinreichung

References

	Scope	Document part	Language	Document
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63g (4)	NIS	§ 63g (4)	DE	DEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 64 Absatz 3	MD	§ 64 Absatz 3	DE	DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.4.3	NIS	VIII.B.4.3	EN	EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017)
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 5	MD	Article 77 Paragraph 5	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 37 Paragraph 4	HM	Article 37 Paragraph 4	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 Annex III 2. ; 3.	G	Annex III 2. ; 3.	EN	EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12
GBR HRA - Ending your project 28-Jan-2025 -	G	-	EN	GBR HRA - Ending your project 28-Jan-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (7)-001	MD	§ 812.150 (b) (7)	EN	USA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (7)-002	MD	§ 812.150 (b) (7)	EN	USA 21 CFR Part 812 09-Apr-2025
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.16	HM	4.16	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995