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- Reference:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 Page 6 +
- Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex A A5.3 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 28 Paragraph 1 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 28 Paragraph 2-3 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 1 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 2 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 3-5 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 6-8 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 34 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 1 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 2 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 3 – 5 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 6 – 7 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 1 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 2 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 3 – 5 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 6 – 7 +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 96 Nr. 10, 11, 21 +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 28 Absatz 1 – 2 +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 28 Absatz 3 +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 28 Absatz 4 – 6 +
- Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.4 +
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 1 1.2 +
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 5 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 3-001 +
- Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (g) +
- Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.102 (e) (1) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (p) +
- Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (k)-002 +
