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- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 14.3 + (Appendix B 14.3)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 16 + (Appendix B 16)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 2.5 + (Appendix B 2.5)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-001 + (Appendix B 4.8)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-002 + (Appendix B 4.8)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 5 + (Appendix B 5)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 6-001 + (Appendix B 6)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 6-002 + (Appendix B 6)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 8 + (Appendix B 8)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 9.4 + (Appendix B 9.4)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B. B4 + (Appendix B. B4)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix C-001 + (Appendix C)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix C-002 + (Appendix C)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix C 2 + (Appendix C 2)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix C C.2.3 + (Appendix C C.2.3)
- Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 Appendix I + (Appendix I)
- Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix I + (Appendix I)
- Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix II + (Appendix II)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 10 + (Article 10)
- Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (b)-001 + (Article 10 (b))
- Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (b)-002 + (Article 10 (b))
- Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (c) + (Article 10 (c))
- Reference:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 Article 107m (1) + (Article 107m (1))
- Reference:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 Article 107n + (Article 107n)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 109 Paragraph 1-001 + (Article 109 Paragraph 1)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 109 Paragraph 1-002 + (Article 109 Paragraph 1)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 11 + (Article 11)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 11 + (Article 11)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 11 - 12 + (Article 11 - 12)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 12 + (Article 12)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 13 + (Article 13)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 14 + (Article 14)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 14 + (Article 14)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 15 + (Article 15)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (1) - (6) + (Article 15 (1) - (6))
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (5) (d) + (Article 15 (5) (d))
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (5) (k)-(l) + (Article 15 (5) (k)-(l))
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (7) - (10) + (Article 15 (7) - (10))
- Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 15 1. - 4. + (Article 15 1. - 4.)
- Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 15 6. - 7.-001 + (Article 15 6. - 7.)
- Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 15 6. - 7.-002 + (Article 15 6. - 7.)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 16 + (Article 16)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 16 + (Article 16)
- Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 16 + (Article 16)
- Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 16 (1) - (3) + (Article 16 (1) - (3))
- Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 16 (11) + (Article 16 (11))
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 17 + (Article 17)
- Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 17 + (Article 17)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 17 Paragraph 1-3 + (Article 17 Paragraph 1-3)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 17 Paragraph 4-5 + (Article 17 Paragraph 4-5)
- Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 18 + (Article 18)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 18 + (Article 18)