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- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 5 (5) +
- Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (c) +
- Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 16 (11) +
- Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 15 6. - 7.-002 +
- Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.113-002 +
- Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.113 +
- Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.123 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.38 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.42 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.44 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.45 +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (q) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b) - (c)-002 +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (2) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (1) - (3) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (7)-001 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4.5.2 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 8.3 +
- 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 +