| | Scope | Document part | Language | Document |
|---|
| DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40c-001 | G | § 40c | DE | DEU AMG - Arzneimittelgesetz 19-Jul-2023 |
| DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 g Absatz 3 | HM | § 63 g
Absatz 3 | DE | DEU AMG - Arzneimittelgesetz 19-Jul-2023 |
| DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.3 | NIS | Leitlinie 6
6.3 | DE | DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 |
| DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.4 | NIS | 2.4 | DE | DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 |
| DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 9 | G | § 9 | DE | DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 54 | MD | § 54 | DE | DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 |
| GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 11 | HM | Article 11 | EN | GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 |
| GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 22-23 | HM | Article 22-23 | EN | GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 |
| GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 24 | HM | Article 24 | EN | GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 |
| GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 25 | HM | Article 25 | EN | GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 |
| ICH ICH E6 Guideline R3 (2025) Appendix B | G | Appendix B | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Protocol Amendment | G | GLOSSARY - Protocol Amendment | EN | ICH ICH E6 Guideline R3 (2025) |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.5.1 | MD | 7.5.1 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.30 | HM | § 312.30 | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.30 (b) (ii) | HM | § 312.30
(b) (ii) | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.31 | HM | § 312.31 | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 56 09-Apr-2025 § 56.110 (b) (2) | G | § 56.110
(b) (2) | EN | USA 21 CFR Part 56 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.35 | MD | § 812.35 | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 45 CFR Part 160 09-Apr-2025 § 164.526 | G | § 164.526 | EN | USA 45 CFR Part 160 09-Apr-2025 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 2 | HM | 2 | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Responsibility | HM | 3.2 - Responsibility | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - Amendment | HM | 4.4 - Amendment | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WMA Declaration of Helsinki 2024 Paragraph 23 - Amendment approval | G | Paragraph 23 - Amendment approval | EN | WMA Declaration of Helsinki 2024 |
