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• Reference:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021 2.-001  + (5.2.4)
• Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-002  + (5.2.4)
• Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 7.2  + (5.2.4)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64 (b)  + (5.2.4)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (a) (3) (ii)  + (5.2.4)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (1)  + (5.2.4)
• Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; IV.  + (5.2.4)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.3  + (5.2.4)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 4.3  + (5.2.4)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 Appendix 1  + (5.2.4)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.1  + (5.2.4)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.2  + (5.2.4)
• Reference:ICH ICH E2A Guideline 1994 III B. - III C.  + (5.3.1)
• Reference:ICH ICH E2A Guideline 1994 III E  + (5.3.1)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.2 (a) - (b) ; (d) - (f)  + (5.3.1)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.13  + (5.3.1)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Sponsor  + (5.3.1)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.2 - Sponsor  + (5.3.1)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Independent Data Monitoring Committee (IDMC)  + (5.3.2)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.9  + (5.3.2)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 8  + (5.3.2)
• Reference:ICH ICH E9 Guideline 1998 Glossary - IDMC  + (5.3.2)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Committee  + (5.3.2)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 13  + (5.3.2)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 78  + (5.3.2)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.5  + (5.3.2)

• Reference:ICH ICH E2F Guideline 2010 1  + (5.3.3)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.2 (c)  + (5.3.3)

• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 41-002  + (5.3.4)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 42  + (5.3.4)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 43  + (5.3.4)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 53  + (5.3.4)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 1, 3 & 4  + (5.3.5)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 1-2  + (5.3.5)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 3  + (5.3.5)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 4  + (5.3.5)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 5 – 6  + (5.3.5)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 87 Paragraph 1 – 2  + (5.3.5)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 87 Paragraph 3 – 5  + (5.3.5)
• Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-001  + (5.3.5)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 1  + (5.3.5)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 73 Paragraph 1, 3, 4  + (5.3.5)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 2 – 3  + (5.3.5)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 4  + (5.3.5)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 5 – 6  + (5.3.5)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 82 Paragraph 3 – 5  + (5.3.5)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 6-002  + (5.3.6)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-003  + (5.3.6)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 63  + (5.3.6)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 64  + (5.3.6)
• Reference:AUT MPG – Medizinproduktegesetz 26-May-2022 § 22  + (5.3.6)
• Reference:FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 3.  + (5.3.6)