Glossary:TAG-00343-Doc-ten

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Documentation
Tag-ID	TAG-00343-Doc-ten
English	Documentation / Trial documentation / Study documentation / Document management / Recordkeeping / Record management / Document control
French	Documentation / Documentation de l'essai / Documentation de l'étude / Gestion des documents / Tenue des dossiers / Gestion des enregistrements / Contrôle des documents
German	Dokumentation / Studiendokumentation / Prüfungsdokumentation / Dokumentenverwaltung / Aktenführung / Unterlagenverwaltung / Dokumentenkontrolle

References

	Scope	Document part	Language	Document
AUT Ärztegesetz 08-Mar-2023 § 51 (3)	G	§ 51 (3)	DE	AUT Ärztegesetz 08-Mar-2023
DEU AMWHV – Arzneimittel- und Wirkstoffherstellungs-verordnung 09-Aug-2019 § 20	HM	§ 20	DE	DEU AMWHV – Arzneimittel- und Wirkstoffherstellungs-verordnung 09-Aug-2019
DEU BGB - Bürgerliches Gesetzbuch 22-Dec-2023 § 630	G	§ 630	DE	DEU BGB - Bürgerliches Gesetzbuch 22-Dec-2023
DEU Bundestag - Sachstand zur Aufbewahrung von Patientenakten in der ambulanten Praxis Fristen und Form 01-Mar-2021 -	G	-	DE	DEU Bundestag - Sachstand zur Aufbewahrung von Patientenakten in der ambulanten Praxis Fristen und Form 01-Mar-2021
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.7	NIS	Leitlinie 3 3.7	DE	DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 7	NIS	Leitlinie 7	DE	DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.2.1 - Ende	NIS	2.2.1 - Ende	DE	DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.2.1 - Start	NIS	2.2.1 - Start	DE	DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022
DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021 § 10 Absatz 3	G	§ 10 Absatz 3	DE	DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 33 Absatz 2	MD	§ 33 Absatz 2	DE	DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 4.	G	4.	EN	EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017
EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 Page 6	G	Page 6	EN	EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022
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 Eudralex - volume 4 GMP Guidelines Chapter 4 Jan-2011 4	G	4	EN	EU Eudralex - volume 4 GMP Guidelines Chapter 4 Jan-2011
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) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter II Section 1.7	MD	Annex XV Chapter II Section 1.7	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III 1. ; 3.	MD	Annex XV Chapter III 1. ; 3.	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III Paragraph 3	MD	Annex XV Chapter III Paragraph 3	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 3 – 4-001	MD	Article 72 Paragraph 3 – 4	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 3 – 4-002	MD	Article 72 Paragraph 3 – 4	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter I Section 1.8	IVD	Annex XIV Chapter I Section 1.8	EN	EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 3-001	IVD	Annex XIV Chapter II Section 3	EN	EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 3-002	IVD	Annex XIV Chapter II Section 3	EN	EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 3 – 4-001	IVD	Article 68 Paragraph 3 – 4	EN	EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 3 – 4-002	IVD	Article 68 Paragraph 3 – 4	EN	EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section K No. 59-60	HM	ANNEX I Section K No. 59-60	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 56	HM	Article 56	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
FRA DHOS/E1/DAF/DPACI no 2007-322 14-Aug-2007 2.1	G	2.1	FR	FRA DHOS/E1/DAF/DPACI no 2007-322 14-Aug-2007
FRA DHOS/E1/DAF/DPACI no 2007-322 14-Aug-2007 2.1.2	G	2.1.2	FR	FRA DHOS/E1/DAF/DPACI no 2007-322 14-Aug-2007
ICH ICH E6 Guideline R3 (2025) Appendix B 14.3	G	Appendix B 14.3	EN	ICH ICH E6 Guideline R3 (2025)
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.4.3-001	MD	7.4.3	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 7.4.3-002	MD	7.4.3	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
USA 21 CFR Part 312 09-Apr-2025 § 312.57-001	HM	§ 312.57	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.57-002	HM	§ 312.57	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.62	HM	§ 312.62	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.62 (c)	HM	§ 312.62 (c)	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 54 09-Apr-2025 § 54.6	G	§ 54.6	EN	USA 21 CFR Part 54 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 Subpart G	MD	Subpart G	EN	USA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.140 (a) (3) (ii)	MD	§ 812.140 (a) (3) (ii)	EN	USA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.140 (b) (5)	MD	§ 812.140 (b) (5)	EN	USA 21 CFR Part 812 09-Apr-2025
USA 45 CFR Part 160 09-Apr-2025 § 164.526	G	§ 164.526	EN	USA 45 CFR Part 160 09-Apr-2025
USA 45 CFR Part 46 09-Apr-2025 § 46.115	G	§ 46.115	EN	USA 45 CFR Part 46 09-Apr-2025
USA FDA - HUMAN DRUG CGMP NOTES Volume 8, Number 3 6	G	6	EN	USA FDA - HUMAN DRUG CGMP NOTES Volume 8, Number 3
WHO WHO - EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS Forty-fifth report -	G	-	EN	WHO WHO - EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS Forty-fifth report
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8	HM	8	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995