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• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.6  + (4.6)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.7  + (4.7)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.8  + (4.8)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.8 - 4.9  + (4.8 - 4.9)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5  + (5)
• Reference:EU INS/GCP/46309/2012 - Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP 2012 5  + (5)
• Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 5 - 6  + (5 - 6)
• Reference:ICH ICH E8 Guideline R1 (2021) 5.  + (5.)
• Reference:FRA SURV VIG DOC118 V01 REC-Avis aux promoteurs -Partie V 16-May-2025 5.  + (5.)
• Reference:ICH ICH E8 Guideline R1 (2021) 5.1  + (5.1)
• Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 5.1  + (5.1)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.1  + (5.1)
• Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 5.1 - 5.2-001  + (5.1 - 5.2)
• Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 5.1 - 5.2-002  + (5.1 - 5.2)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.12  + (5.12)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.13  + (5.13)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.14  + (5.14)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.2  + (5.2)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.1  + (5.3.1)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.2  + (5.3.2)
• Reference:ICH ICH E8 Guideline R1 (2021) 5.6  + (5.6)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.6  + (5.6)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.6.6.1  + (5.6.6.1)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.7  + (5.7)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.2  + (5.8.2)

• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.3  + (5.8.3)

• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.4 - 5.8.6  + (5.8.4 - 5.8.6)
• 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)