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- 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: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) +
- Reference:GBR The Human Medicines Regulations 2012 01-Jan-2025 Article 51B +
- Reference:GBR Directive 93/42/EEC 11-Oct-2007 ANNEX X 2.1 +
- Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 18 +
- Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (c) +
- Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.110 (a) - (b) (1) +
- Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.102 (b) +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 - Clinical investigation +
- Reference:USA 21 CFR Part 320 09-Apr-2025 § 320.22 +
- Reference:USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998 - +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.1 +
