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List of results
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.6 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.17.1 +
- Reference:ICH ICH E9 Guideline 1998 4.5 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.15 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.14 +
- Reference:WMA Declaration of Helsinki 2024 34 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 8.2 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 26 - 29 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 37 Paragraph 1 – 7 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 38 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 76 Paragraph 3 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 1 – 3 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 5 +
- Reference:FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 2.-002 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. (p) +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 27 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 5 (5) +
- Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (c) +
- Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 16 (11) +
- Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 15 6. - 7.-002 +
- Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.113-002 +
- Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.113 +
- Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.123 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.38 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.42 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.44 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.45 +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (q) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b) - (c)-002 +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (2) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (1) - (3) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (7)-001 +
