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- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 7 – 8 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 1.12 +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-001 +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3 Absatz 5 – 6 +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 30-002 +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 62-001 +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 65 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (viii) +
- Reference:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. A. +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.2 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.7 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.3 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 50 +
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.9 +
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.4 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (5) (d) +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.5 +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Agreement +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.6 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.14-001 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - contract +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.11 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.9 +
- Reference:DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021 § 33 +
- Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.7 +
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 9 +
- Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 Article R1121-3-1 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (5) (k)-(l) +
- Reference:GBR IRAS - Integrated Research Application System 28-Jan-2025 Templates +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) +
