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- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 10.3 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 10.4 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - medical device-002 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.9 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.4.3-001 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 51 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 66 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 67 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 68 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 69 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 investigational medicinal product +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 7 Part 2 2. +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 12. +
- Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (j) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (g) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (m) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (r) +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.6 - §312.8 ; § 312.10 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.40 (c) (d) +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (b) +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.61 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 (a) +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.69 +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.110 (c) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (a) (2) +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Compliance (in relation to trials) +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.5 +
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 2.5 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - Introduction +
- Reference:WHO WHO - Guidance for best practices for clinical trials 2024 3.2.4 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.6 +
