Glossary:TAG-00152-Tri-gat

Glossary > Trial master file

Trial master file
Tag-ID	TAG-00152-Tri-gat
English	Trial master file / Investigator site file / Study file
EN Abbr.	TMF / ISF
French	Dossier permanent de l'essai / Classeur investigateur / Dossier de l'étude
FR Abbr.	DPE / TMF / CI
German	Trial Master File / Investigator Site File / Prüfungsakte
DE Abbr.	TMF / ISF

References

	Scope	Document part	Language	Document
AUT BASG - FAQ 11-Feb-2025 Schwarz	G	Schwarz	DE	AUT BASG - FAQ 11-Feb-2025
EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3	G	3	EN	EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018
EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3.5.2	G	3.5.2	EN	EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018
EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3.5.3	G	3.5.3	EN	EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018
EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.5	HM	4.5	EN	EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017
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
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 58	HM	Article 58	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
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)