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- Reference:ICH ICH E6 Guideline R3 (2025) Appendix C 2 +
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 14.3 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8.3 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 58 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 3 – 4-002 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III 1. ; 3. +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 3 – 4-002 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 3-002 +
- Reference:DEU AMWHV – Arzneimittel- und Wirkstoffherstellungs-verordnung 09-Aug-2019 § 20 +
- Reference:DEU BGB - Bürgerliches Gesetzbuch 22-Dec-2023 § 630 +
- Reference:DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021 § 10 Absatz 3 +
- Reference:DEU Bundestag - Sachstand zur Aufbewahrung von Patientenakten in der ambulanten Praxis Fristen und Form 01-Mar-2021 - +
- Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.6 +
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 8 +
- Reference:AUT Ärztegesetz 08-Mar-2023 § 51 (3) +
- Reference:FRA DHOS/E1/DAF/DPACI no 2007-322 14-Aug-2007 2.1 +
- Reference:FRA DHOS/E1/DAF/DPACI no 2007-322 14-Aug-2007 2.1.2 +
- Reference:GBR NHS: Records Management Code of Practice 07-Aug-2023 - +
- Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.6 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.57-002 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 (c) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (d) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (e) +
- Reference:USA 45 CFR Part 160 09-Apr-2025 § 164.526 +
- Reference:USA 45 CFR Part 160 09-Apr-2025 § 164.530 +
