Glossary:TAG-00341-Res-ben

Glossary > Responsibilities

Responsibilities
Tag-ID	TAG-00341-Res-ben
English	Responsibilities / Obligations / Duties / Accountability / Tasks
French	Responsabilités / Obligations / Devoirs / Tâches / Redevabilité
German	Verantwortlichkeiten / Pflichten / Aufgaben / Zuständigkeiten / Rechenschaftspflicht

References

	Scope	Document part	Language	Document
DEU BGB - Bürgerliches Gesetzbuch 22-Dec-2023 § 630	G	§ 630	DE	DEU BGB - Bürgerliches Gesetzbuch 22-Dec-2023
DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021 § 15	G	§ 15	DE	DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 85	MD	§ 85	DE	DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.2	G	4.2	EN	EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 5-6	HM	Article 5-6	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sponsor	G	GLOSSARY - Sponsor	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 1	G	III. Annex 1 1	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3	G	III. Annex 1 4.3	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.4	G	III. Annex 1 4.3.4	EN	ICH ICH E6 Guideline R3 (2025)
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.1	MD	6.1	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
N.A. Article from Mora et al. 2023 -	G	-	EN	N.A. Article from Mora et al. 2023
USA 21 CFR Part 812 09-Apr-2025 Subpart D	MD	Subpart D	EN	USA 21 CFR Part 812 09-Apr-2025
USA 42 CFR Part 11 09-Apr-2025 § 11.4	G	§ 11.4	EN	USA 42 CFR Part 11 09-Apr-2025
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 11	HM	11	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 - Introduction	HM	3.2 - Introduction	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.17	HM	4.17	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995