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• Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.3  + (Annex 2 2.3)
• Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.3.2  + (Annex 2 2.3.2)
• Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.4 - 2.5  + (Annex 2 2.4 - 2.5)
• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 Annex 2 2.5  + (Annex 2 2.5)
• Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 3  + (Annex 2 3)
• Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 Introduction  + (Annex 2 Introduction)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex 5 A5.2  + (Annex 5 A5.2)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.17  + (Annex A A.17)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.5  + (Annex A A.5)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-001  + (Annex A A.6.3)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-002  + (Annex A A.6.3)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.7  + (Annex A A.7)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex A A5.3  + (Annex A A5.3)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - CIP  + (Annex A - CIP)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - medical device-001  + (Annex A - medical device)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - medical device-002  + (Annex A - medical device)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex B  + (Annex B)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex D  + (Annex D)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex E-001  + (Annex E)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex E-002  + (Annex E)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex F  + (Annex F)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex I  + (Annex I)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex I 6.3  + (Annex I 6.3)
• Reference:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 Annex III 1.  + (Annex III 1.)
• Reference:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 Annex III 2. ; 3.  + (Annex III 2. ; 3.)

• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex J  + (Annex J)

• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex VIII  + (Annex VIII)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex VIII  + (Annex VIII)
• Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex VIII 1. ; 2.  + (Annex VIII 1. ; 2.)
• Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex VIII 1. ; 2. ; 2.2  + (Annex VIII 1. ; 2. ; 2.2)
• Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X  + (Annex X)
• Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X 2.2  + (Annex X 2.2)
• Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X 2.3.7  + (Annex X 2.3.7)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIII Part A Section 2.3  + (Annex XIII Part A Section 2.3)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter I Section 1.8  + (Annex XIV Chapter I Section 1.8)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 3-001  + (Annex XIV Chapter II Section 3)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 3-002  + (Annex XIV Chapter II Section 3)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 4  + (Annex XIV Chapter II Section 4)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 1.12  + (Annex XIV Chapter II Section 1.12)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 2  + (Annex XIV Chapter II Section 2)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter I Section 2  + (Annex XV Chapter I Section 2)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter II Section 1.7  + (Annex XV Chapter II Section 1.7)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III 1. ; 3.  + (Annex XV Chapter III 1. ; 3.)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III 2. ; 7.  + (Annex XV Chapter III 2. ; 7.)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III Paragraph 3  + (Annex XV Chapter III Paragraph 3)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III Section 4  + (Annex XV Chapter III Section 4)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 Appendix 1  + (Appendix 1)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Appendix 2  + (Appendix 2)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix A  + (Appendix A)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix A 3.4  + (Appendix A 3.4)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B  + (Appendix B)