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- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 1.4 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.2 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.2 +
- Reference:N.A. Article from Mora et al. 2023 - +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 25 +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 30-001 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 investigator +
- Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (d) +
- Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (h) +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 - Investigator +
- Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.4 disclosure +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi) +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.60-001 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64-001 +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (e) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (i) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.43 (c) (4) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart E +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.3 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.1 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.6 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.1 +
- Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - Organisation +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 49 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-002 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 4 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 5-002 +
