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Glossary:TAG-00050-Cli-ber

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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

 ScopeDocument partLanguageDocument
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 6 – 7MDArticle 63 Paragraph 6 – 7ENEU 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 – 7MDArticle 77 Paragraph 6 – 7ENEU 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 – 7IVDArticle 59 Paragraph 6 – 7ENEU 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 – 7IVDArticle 77 Paragraph 6 – 7ENEU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
GBR Directive 93/42/EEC 11-Oct-2007 Annex X 2.3.7MDAnnex X 2.3.7ENGBR Directive 93/42/EEC 11-Oct-2007
ICH ICH E3 Guideline 1995 -G-ENICH ICH E3 Guideline 1995
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Clinical Trial/Study Report (CSR)GGLOSSARY - Clinical Trial/Study Report (CSR)ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.10.1.6GIII. Annex 1 3.10.1.6ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 3.17.2GIII. Annex 3.17.2ENICH ICH E6 Guideline R3 (2025)
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex DMDAnnex DENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.12HM5.12ENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - final reportHMGlossary - final reportENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
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