Glossary:TAG-00250-Inv-sme

Glossary > Investigator safety reporting

Investigator safety reporting
Tag-ID	TAG-00250-Inv-sme
English	Investigator reporting to sponsor / Investigator safety reporting / Investigator report to sponsor
French	Déclaration de l'investigateur au promoteur / Rapport de sécurité de l'investigateur / Rapport de l'investigateur au promoteur
German	Meldung des Prüfers an den Sponsor / Sicherheitsmeldung des Prüfers / Prüferbericht an den Sponsor

References

	Scope	Document part	Language	Document
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 63	MD	§ 63	DE	DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-001	MD	8.2	EN	EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-002	MD	8.2	EN	EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 41-001	HM	Article 41	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 41-002	HM	Article 41	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
GBR Directive 2001/20/EC 04-Apr-2001 Article 16	HM	Article 16	EN	GBR Directive 2001/20/EC 04-Apr-2001
GBR MEDDEV 2.7/3 revision 3 May-2015 7.2	MD	7.2	EN	GBR MEDDEV 2.7/3 revision 3 May-2015
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 32	HM	Article 32	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.8	MD	10.8	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
USA 21 CFR Part 312 09-Apr-2025 § 312.64 (b)	HM	§ 312.64 (b)	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.64-001	HM	§ 312.64	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.64-002	HM	§ 312.64	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (1)	MD	§ 812.150 (a) (1)	EN	USA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (2)	MD	§ 812.150 (a) (2)	EN	USA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (3)	MD	§ 812.150 (a) (3)	EN	USA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (4)	MD	§ 812.150 (a) (4)	EN	USA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (5)	MD	§ 812.150 (a) (5)	EN	USA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (6)	MD	§ 812.150 (a) (6)	EN	USA 21 CFR Part 812 09-Apr-2025
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.10	HM	4.10	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.2 - Investigator	HM	7.2 - Investigator	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995