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- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 9.4 +
- Reference:EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005 2.1 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX III Section 2.1 +
- Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.6.6.1 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.2 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.14-002 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.3 c) +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 76 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 69 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 65 +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40a Absatz 3 +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 26 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 16. +
- Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 3 +
- Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex VIII 1. ; 2. ; 2.2 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.6 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.17.1 +
- Reference:ICH ICH E9 Guideline 1998 4.5 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.15 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.14 +
- Reference:WMA Declaration of Helsinki 2024 34 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 8.2 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 26 - 29 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 37 Paragraph 1 – 7 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 38 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 76 Paragraph 3 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 1 – 3 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 5 +
- Reference:FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 2.-002 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. (p) +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 27 +
