| | 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 |
