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List of results

• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B. B4  +
• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - Clinical Research  +
• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.4  +
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.3  +
• Reference:INT Nuremberg Code 1947 Code  +
• Reference:WMA Declaration of Helsinki 2024 -  +
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - Good Clinical Practice (GCP)  +
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 WHO Principles of GCP  +
• Reference:EUR European Bioethics Convention 1997 -  +
• Reference:ICH ICH E6 Guideline R3 (2025) I  +
• Reference:ICH ICH E6 Guideline R3 (2025) II  +
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Clinical Trial  +
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - clinical trial  +
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.8  +
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - pharmaceutical product  +
• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - NIS  +
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex I 6.3  +
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 1  +
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 2  +
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 3  +
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 4  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 4 – 8  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 10 – 12  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 14  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 46  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 52  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 45  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 62  +
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 4 – 6  +
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 7 – 9  +
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 11  +
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 14  +
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 45  +
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 48  +
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 42  +
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 58  +
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 23  +
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 34  +
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 f Absatz 1 – 3  +
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 g Absatz 1 – 2  +
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 47-001  +
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3  +
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.1-001  +
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.2  +
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.1  +
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 3.1  +
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 clinical trial  +
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 non-interventional trial  +
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (a)  +
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (c)  +