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Glossary:TAG-00055-Stu-ngs

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Glossary > Study design

Study design
Tag-ID TAG-00055-Stu-ngs
English Study design / Trial design / Experimental design
French Schéma de l'étude / Design de l'étude / Schéma expérimental
German Studiendesign / PrĂŒfungsdesign / Versuchsplan

References

 ScopeDocument partLanguageDocument
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.3 - 3.6NISLeitlinie 3 3.3 - 3.6DEDEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018
EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 -HM-ENEU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022
ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-001GAppendix B 4.8ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-002GAppendix B 4.8ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) Appendix B. B4GAppendix B. B4ENICH ICH E6 Guideline R3 (2025)
ICH ICH E8 Guideline R1 (2021) -HM-ENICH ICH E8 Guideline R1 (2021)
ICH ICH E8 Guideline R1 (2021) 3.3.5HM3.3.5ENICH ICH E8 Guideline R1 (2021)
ICH ICH E9 Guideline 1998 IIIHMIIIENICH ICH E9 Guideline 1998
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.7MDAnnex A A.7ENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
USA 21 CFR Part 312 09-Apr-2025 § 312.23 (6) (d)HM§ 312.23 (6) (d)ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 314 09-Apr-2025 § 314.126HM§ 314.126ENUSA 21 CFR Part 314 09-Apr-2025
USA 42 CFR Part 11 09-Apr-2025 § 11.10 (b) (5)G§ 11.10 (b) (5)ENUSA 42 CFR Part 11 09-Apr-2025
WHO WHO - Guidance for best practices for clinical trials 2024 1.4G1.4ENWHO WHO - Guidance for best practices for clinical trials 2024
WHO WHO - Guidance for best practices for clinical trials 2024 2.4G2.4ENWHO WHO - Guidance for best practices for clinical trials 2024
WHO WHO - Guidance for best practices for clinical trials 2024 2.5G2.5ENWHO WHO - Guidance for best practices for clinical trials 2024
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.1HM9.1ENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
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