Glossary:TAG-00055-Stu-ngs

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 / Prüfungsdesign / Versuchsplan

References

	Scope	Document part	Language	Document
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.3 - 3.6	NIS	Leitlinie 3 3.3 - 3.6	DE	DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018
EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 -	HM	-	EN	EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022
ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-001	G	Appendix B 4.8	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-002	G	Appendix B 4.8	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) Appendix B. B4	G	Appendix B. B4	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E8 Guideline R1 (2021) -	HM	-	EN	ICH ICH E8 Guideline R1 (2021)
ICH ICH E8 Guideline R1 (2021) 3.3.5	HM	3.3.5	EN	ICH ICH E8 Guideline R1 (2021)
ICH ICH E9 Guideline 1998 III	HM	III	EN	ICH ICH E9 Guideline 1998
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.7	MD	Annex A A.7	EN	ISO 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)	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 314 09-Apr-2025 § 314.126	HM	§ 314.126	EN	USA 21 CFR Part 314 09-Apr-2025
USA 42 CFR Part 11 09-Apr-2025 § 11.10 (b) (5)	G	§ 11.10 (b) (5)	EN	USA 42 CFR Part 11 09-Apr-2025
WHO WHO - Guidance for best practices for clinical trials 2024 1.4	G	1.4	EN	WHO WHO - Guidance for best practices for clinical trials 2024
WHO WHO - Guidance for best practices for clinical trials 2024 2.4	G	2.4	EN	WHO WHO - Guidance for best practices for clinical trials 2024
WHO WHO - Guidance for best practices for clinical trials 2024 2.5	G	2.5	EN	WHO WHO - Guidance for best practices for clinical trials 2024
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.1	HM	9.1	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995