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• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.2  + (9.2)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.2  + (9.2.2)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.4  + (9.2.4)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.5  + (9.2.5)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.3  + (9.3)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 A4.13  + (A4.13)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No. 17  + (ANNEX I Section D No. 17)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No. 19  + (ANNEX I Section D No. 19)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No.17 ; No. 22  + (ANNEX I Section D No.17 ; No. 22)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section K No. 59-60  + (ANNEX I Section K No. 59-60)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX III Section 2.1  + (ANNEX III Section 2.1)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX VI Section 2.5 No. 17-22  + (ANNEX VI Section 2.5 No. 17-22)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX VI Section D No. 8  + (ANNEX VI Section D No. 8)
• Reference:GBR Directive 93/42/EEC 11-Oct-2007 ANNEX X 2.1  + (ANNEX X 2.1)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 ANNEX XV Chapter III, 6  + (ANNEX XV Chapter III, 6)
• Reference:ICH ICH E8 Guideline R1 (2021) ANNEX: TYPES OF CLINICAL STUDIES  + (ANNEX: TYPES OF CLINICAL STUDIES)
• Reference:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 Annex 1  + (Annex 1)
• Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.2  + (Annex 2 2.2)
• 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)