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• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.3 c)  + (3.3 c))
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.3 c) ; e) - g)  + (3.3 c) ; e) - g))
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.3 e) - g)  + (3.3 e) - g))
• Reference:ICH ICH E8 Guideline R1 (2021) 3.3.5  + (3.3.5)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.33  + (3.33)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.42 - randomization  + (3.42 - randomization)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.42 - recruitment  + (3.42 - recruitment)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.45  + (3.45)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.46  + (3.46)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.47  + (3.47)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.48  + (3.48)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.5  + (3.5)
• 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 3.5.2  + (3.5.2)
• 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 3.5.3  + (3.5.3)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.51  + (3.51)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.52  + (3.52)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.55  + (3.55)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.8  + (3.8)
• Reference:WMA Declaration of Helsinki 2024 34  + (34)
• Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 4  + (4)
• Reference:EU Eudralex - volume 4 GMP Guidelines Chapter 4 Jan-2011 4  + (4)
• Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 4  + (4)
• Reference:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 4.  + (4.)
• Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.1  + (4.1)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.1  + (4.1)

• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.10  + (4.10)

• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.11  + (4.11)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-001  + (4.12)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-002  + (4.12)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-003  + (4.12)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.15  + (4.15)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.16  + (4.16)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.17  + (4.17)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.2  + (4.2)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.2  + (4.2)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.3  + (4.3)
• Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 4.3  + (4.3)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 4.3  + (4.3)
• Reference:ICH ICH E8 Guideline R1 (2021) 4.3.3.1  + (4.3.3.1)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.4  + (4.4)
• Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.4  + (4.4)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - Amendment  + (4.4 - Amendment)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - Introduction  + (4.4 - Introduction)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - immediate hazard  + (4.4 - immediate hazard)
• Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.5  + (4.5)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.5  + (4.5)
• Reference:ICH ICH E9 Guideline 1998 4.5  + (4.5)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 ALCOA  + (4.5 ALCOA)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 CCEAT  + (4.5 CCEAT)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.6  + (4.6)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.6  + (4.6)