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- Reference:ICH ICH E8 Guideline R1 (2021) 6.2.2 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - immediate hazard +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.6 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-002 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 30-001 +
- Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (b)-001 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.30 (b) (ii) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (4) +
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-002 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.46 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.4.3-002 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 54 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 77 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 6 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 76 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 1 +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b) +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42 +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 66 +
- Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 11 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 30-002 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 31 +
- Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (b)-002 +
- Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 15 6. - 7.-001 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.44 (d) +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.56 +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.7 (c) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.30 (b) - (c) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b) - (c)-001 +
- Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.113-001 +
- Reference:ICH ICH E8 Guideline R1 (2021) 4.3.3.1 +
