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- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Vulnerable Participants +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.9 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 1.2.7 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.12 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.13 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.8 +
- Reference:ICH ICH E6 Guideline R3 (2025) II 2.4 +
- Reference:ICH ICH E21 Concept paper 2023 2. +
- Reference:CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 19 +
- Reference:CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 18 +
- Reference:ICH ICH E11 Guideline R1 (2017) - +
- Reference:ICH ICH E11 Guideline R1 (2017) 8 +
- Reference:ICH ICH E7 Guideline 1993 - +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.3 e) - g) +
- Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 22 +
- Reference:WHO WHO - Guidance for best practices for clinical trials 2024 2.1.3 +
- Reference:WMA Declaration of Helsinki 2024 Paragraph 29 – 30 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.55 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.7 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.3 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.4 - 5.8.6 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 31 Paragraph 1 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 31 Paragraph 2-3 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 32 Paragraph 1 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 32 Paragraph 2-3 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 33 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 35 Paragraph 1 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 35 Paragraph 2-3 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 64 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 65 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 66 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 68 +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 1 +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 2 +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 3 +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 4 +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 5 +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 6-001 +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 3-002 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 4 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 5 +
- Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (m) +
- Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (n) +
- Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (o) +
- Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (p) +
- Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (q) +
- Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (r) +
- Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (s) +
- Reference:USA 21 CFR Part 50 09-Apr-2025 Subpart D +
