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- Reference:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021 2.-002 + (5.3.6)
- Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-002 + (5.3.6)
- Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 4 + (5.3.6)
- Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 5 - 6 + (5.3.6)
- Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 7.1 + (5.3.6)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 (b) + (5.3.6)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 (c) + (5.3.6)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 (d) + (5.3.6)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.33 (a) - (b) + (5.3.6)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (b) (5) + (5.3.6)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (1) + (5.3.6)
- Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; Evaluation + (5.3.6)
- Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.4 + (5.3.6)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.1-002 + (5.4.1)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix A 3.4 + (5.4.1)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-001 + (5.4.1)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 6-002 + (5.4.1)
- Reference:ICH ICH E9 Guideline 1998 Glossary - Dropout + (5.4.1)
- Reference:ICH ICH E8 Guideline R1 (2021) 6.2.2 + (5.4.1)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - immediate hazard + (5.4.1)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.6 + (5.4.1)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-002 + (5.4.1)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 30-001 + (5.4.1)
- Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (b)-001 + (5.4.1)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.30 (b) (ii) + (5.4.1)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (4) + (5.4.1)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-002 + (5.4.2)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.46 + (5.4.2)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.4.3-002 + (5.4.2)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 54 + (5.4.3)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 77 + (5.4.3)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 6 + (5.4.3)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 76 + (5.4.3)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 + (5.4.3)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 1 + (5.4.3)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b) + (5.4.3)
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42 + (5.4.3)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 66 + (5.4.3)
- Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 11 + (5.4.3)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 30-002 + (5.4.3)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 31 + (5.4.3)
- Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (b)-002 + (5.4.3)
- Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 15 6. - 7.-001 + (5.4.3)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.44 (d) + (5.4.3)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.56 + (5.4.3)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.7 (c) + (5.4.3)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.30 (b) - (c) + (5.4.3)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b) - (c)-001 + (5.4.3)
- Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.113-001 + (5.4.3)
- Reference:ICH ICH E8 Guideline R1 (2021) 4.3.3.1 + (5.4.4)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 9.4 + (5.4.4)
- 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 + (5.4.4)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX III Section 2.1 + (5.4.4)
