Glossary:TAG-00050-Cli-ber

Glossary > Clinical study report

Clinical study report
Tag-ID	TAG-00050-Cli-ber
English	Clinical study report / Clinical trial report
EN Abbr.	CSR
French	Rapport d'étude clinique / Rapport d'essai clinique
FR Abbr.	REC
German	Studienabschlussbericht / Klinischer Studienbericht / Abschlussbericht der klinischen Prüfung
DE Abbr.	SAB

References

	Scope	Document part	Language	Document
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 6 – 7	MD	Article 63 Paragraph 6 – 7	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 6 – 7	MD	Article 77 Paragraph 6 – 7	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 Article 59 Paragraph 6 – 7	IVD	Article 59 Paragraph 6 – 7	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 77 Paragraph 6 – 7	IVD	Article 77 Paragraph 6 – 7	EN	EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
GBR Directive 93/42/EEC 11-Oct-2007 Annex X 2.3.7	MD	Annex X 2.3.7	EN	GBR Directive 93/42/EEC 11-Oct-2007
ICH ICH E3 Guideline 1995 -	G	-	EN	ICH ICH E3 Guideline 1995
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Clinical Trial/Study Report (CSR)	G	GLOSSARY - Clinical Trial/Study Report (CSR)	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.10.1.6	G	III. Annex 1 3.10.1.6	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 3.17.2	G	III. Annex 3.17.2	EN	ICH ICH E6 Guideline R3 (2025)
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex D	MD	Annex D	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.12	HM	5.12	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - final report	HM	Glossary - final report	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995