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- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-003 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 6. +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi) - (vii) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.46 (a) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.110 (b) +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.12 +
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 12.3 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.70 +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.119 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.9.3 +
- 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 +
- Reference:GBR Guidance - Good clinical practice for clinical trials 16-Oct-2015 - +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 52 +
- 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 +
- 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 +
- 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 +
- 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 +
- 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 +
- Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 Appendix I +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 29A +
- Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Who should notify +
- Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Investigator/Institution +
- Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D When should the notification be made +
- Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D What needs to be reported +
- Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix I +
- Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix II +
- Reference:USA FDA Information - Observations and citations 20-Mar-2024 - +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Data Integrity +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Source Records +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Metadata +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Certified Copy +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.1 - 2.12.3 +
