Glossary:TAG-00131-Ess-sun

Glossary > Essential documents

Essential documents
Tag-ID	TAG-00131-Ess-sun
English	Essential records / Essential documents / Trial master file contents
French	Enregistrements essentiels / Documents essentiels / Contenu du dossier permanent
German	Wesentliche Unterlagen / Prüfungsunterlagen / Essentielle Dokumente

References

	Scope	Document part	Language	Document
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 57	HM	Article 57	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 10.	HM	Schedule 1 Part 2 10.	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
ICH ICH E6 Guideline R3 (2025) Appendix C 2	G	Appendix C 2	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) Appendix C C.2.3	G	Appendix C C.2.3	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) Appendix C-001	G	Appendix C	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) Appendix C-002	G	Appendix C	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.11 – 2.12.14	G	III. Annex 1 2.12.11 – 2.12.14	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4.5.2	G	III. Annex 1 3.11.4.5.2	EN	ICH ICH E6 Guideline R3 (2025)
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 8.3	MD	8.3	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex E-001	MD	Annex E	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex E-002	MD	Annex E	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020