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- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.33 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.52 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex F +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 64 – 66 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 67–69 +
- Reference:DEU MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung 21-Apr-2021 § 2 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.2 (a) - (d) +
- Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.4 - 2.5 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.10 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Investigator +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.2 - Investigator +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.8 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 41-001 +
- Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-001 +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-002 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 32 +
- Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 16 +
- Reference:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021 2.-001 +
- Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-002 +
- Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 7.2 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64 (b) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (a) (3) (ii) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (1) +
- 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. +
- Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.3 +
- Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 4.3 +
- Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 Appendix 1 +
- Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.1 +
- Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.2 +
- Reference:ICH ICH E2A Guideline 1994 III B. - III C. +
- Reference:ICH ICH E2A Guideline 1994 III E +
