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• Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 8  + (5.1.3)
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (n)  + (5.1.3)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Suspected adverse reaction  + (5.1.3)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.2  + (5.1.3)
• Reference:ICH ICH E2A Guideline 1994 II A. 3.  + (5.1.4)
• Reference:ICH ICH E2A Guideline 1994 III A. 1.  + (5.1.4)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Suspected Unexpected Serious Adverse Reaction (SUSAR)  + (5.1.4)
• Reference:ICH ICH E2A Guideline 1994 III A. 2.  + (5.1.4)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.51  + (5.1.4)
• Reference:EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.3  + (5.1.4)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 unexpected adverse reaction  + (5.1.4)
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (p)  + (5.1.4)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Unexpected adverse event  + (5.1.4)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (s)  + (5.1.4)
• Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 III A. ; IV.  + (5.1.4)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.32 - 2.1.34  + (5.1.4)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.1  + (5.1.6)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.19  + (5.1.6)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.33  + (5.1.6)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.52  + (5.1.6)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex F  + (5.1.6)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 64 – 66  + (5.1.6)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 67–69  + (5.1.6)
• Reference:DEU MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung 21-Apr-2021 § 2  + (5.1.6)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.2 (a) - (d)  + (5.2.1)
• Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.4 - 2.5  + (5.2.1)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.10  + (5.2.1)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Investigator  + (5.2.1)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.2 - Investigator  + (5.2.1)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.8  + (5.2.1)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 41-001  + (5.2.2)
• Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-001  + (5.2.3)

• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-002  + (5.2.4)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 32  + (5.2.4)
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 16  + (5.2.4)
• 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)