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- Reference:WMA Declaration of Helsinki 2024 Paragraph 23 - Amendment approval +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Protocol Amendment +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Responsibility +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - Amendment +
- Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - Platform, basket and umbrella trials +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.5.1 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 13 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 15 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 16 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 17 Paragraph 1-3 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 17 Paragraph 4-5 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 18 Paragraph 1-3 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 19 Paragraph 1 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 19 Paragraph 2-4 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 20 Paragraph 1-3 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 20 Paragraph 4-7 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 21 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 22 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 23 Paragraph 1-2 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 23 Paragraph 3-6 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 24 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 75 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 71 +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40c-002 +
- Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 8 +
- Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 9 +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 40 +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 41 +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 42 +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 54 +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 55 +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 59 +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63g (3) +
- Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.4 +
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.3 +
- Reference:AUT BASG - FAQ 11-Feb-2025 Änderung am Personal +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 11 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 22-23 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 24 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 25 +
- Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.110 (b) (2) +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.30 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.31 +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.35 +