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Glossary:TAG-00111-Agr-chr

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Glossary > Written agreement

Written agreement
Tag-ID TAG-00111-Agr-chr
English Agreement / Contract / Written agreement
French Accord / Convention / Contrat
German Vereinbarung / Vertrag / Schriftliche Vereinbarung

References

 ScopeDocument partLanguageDocument
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 9NISLeitlinie 9DEDEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018
DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021 § 33G§ 33DEDEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III 2. ; 7.MDAnnex XV

Chapter III

2. ; 7.
ENEU 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 II Section 2IVDAnnex XIV

Chapter II

Section 2
ENEU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 Article R1121-3-1GArticle R1121-3-1FRFRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025
GBR Medicines and Medical Devices Act 2021 21-Feb-2021 Chapter 2 Article 8GChapter 2 Article 8ENGBR Medicines and Medical Devices Act 2021 21-Feb-2021
ICH ICH E6 Guideline R3 (2025) Appendix B 16GAppendix B 16ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) GLOSSARY - AgreementGGLOSSARY - AgreementENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.5GIII. Annex 1 3.5ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.6GIII. Annex 1 3.6ENICH ICH E6 Guideline R3 (2025)
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.9MD6.9ENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.11HM4.11ENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - contractHMGlossary - contractENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995