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• Reference:USA FDA - HUMAN DRUG CGMP NOTES Volume 8, Number 3 6  + (6)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 6  + (6)
• Reference:ICH ICH E19 Guideline 2022 6  + (6)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.1  + (6.1)
• Reference:ICH ICH E8 Guideline R1 (2021) 6.1.4  + (6.1.4)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 6.2  + (6.2)
• Reference:ICH ICH E8 Guideline R1 (2021) 6.2.2  + (6.2.2)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.3  + (6.3)
• Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 6.4  + (6.4)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.6  + (6.6)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.9  + (6.9)
• Reference:ICH ICH E8 Guideline R1 (2021) 7  + (7)
• Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 7.1  + (7.1)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Committee  + (7.1 - Committee)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Investigator  + (7.1 - Investigator)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Sponsor  + (7.1 - Sponsor)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.11  + (7.11)
• Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 7.2  + (7.2)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.2 - Investigator  + (7.2 - Investigator)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.2 - Sponsor  + (7.2 - Sponsor)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.4.3-001  + (7.4.3)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.4.3-002  + (7.4.3)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.5.1  + (7.5.1)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.5.3  + (7.5.3)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.6  + (7.6)

• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.8  + (7.8)

• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.9  + (7.9)
• Reference:ICH ICH E11 Guideline R1 (2017) 8  + (8)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8  + (8)
• Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 8  + (8)
• Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-001  + (8)
• Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-002  + (8)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8 - Electronic data handling  + (8 - Electronic data handling)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8 - Introduction  + (8 - Introduction)
• Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-001  + (8.2)
• Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-002  + (8.2)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 8.2  + (8.2)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 8.3  + (8.3)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8.3  + (8.3)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9  + (9)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.1  + (9.1)
• 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)