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- Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 3.1 + (3.1)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.1 + (3.1)
- Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 a) + (3.1.2 a))
- Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - ComCompliance + (3.1.2 - ComCompliance)
- Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - Monitoring + (3.1.2 - Monitoring)
- Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - Organisation + (3.1.2 - Organisation)
- Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - Randomisation + (3.1.2 - Randomisation)
- Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - SD + (3.1.2 - SD)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.12 + (3.12)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.19 + (3.19)
- Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 3.2 + (3.2)
- Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 3.2 + (3.2)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.2 + (3.2)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Consultation + (3.2 - Consultation)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Introduction + (3.2 - Introduction)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Responsibility + (3.2 - Responsibility)
- Reference:WHO WHO - Guidance for best practices for clinical trials 2024 3.2.4 + (3.2.4)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.24 + (3.24)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.26 + (3.26)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.29 + (3.29)
- Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 3.3 + (3.3)
- 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)
