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• Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Who should notify  + (4.1.4)
• Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Investigator/Institution  + (4.1.4)
• 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  + (4.1.4)
• Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D What needs to be reported  + (4.1.4)
• Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix I  + (4.1.4)
• Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix II  + (4.1.4)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Data Integrity  + (4.2.1)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Source Records  + (4.2.1)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Metadata  + (4.2.1)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Certified Copy  + (4.2.1)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.1 - 2.12.3  + (4.2.1)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.5 – 2.12.9  + (4.2.1)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.11 – 2.12.14  + (4.2.1)
• Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 Introduction  + (4.2.1)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - patient/subject file  + (4.2.1)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - raw data  + (4.2.1)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8  + (4.2.1)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 94  + (4.2.1)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.47  + (4.2.1)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.48  + (4.2.1)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.5.3  + (4.2.1)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.8  + (4.2.1)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 17  + (4.2.1)
• 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 - 5.2-002  + (4.2.1)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 62-002  + (4.2.1)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.1-002  + (4.2.1)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.7  + (4.2.1)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 7  + (4.2.1)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 10.  + (4.2.1)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 (b)  + (4.2.1)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (a) (3)  + (4.2.1)
• Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 GLOSSARY OF TERMS  + (4.2.1)

• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 2.1.8  + (4.2.2)
• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 2.4  + (4.2.2)
• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 2.5  + (4.2.2)
• Reference:WHO WHO - EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS Forty-fifth report -  + (4.2.2)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.1.4  + (4.2.2)
• Reference:EU Eudralex - volume 4 GMP Guidelines Chapter 4 Jan-2011 4  + (4.2.2)
• 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  + (4.2.2)
• Reference:AUT BASG - FAQ 11-Feb-2025 Schwarz  + (4.2.2)
• Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 2.  + (4.2.2)
• Reference:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015 III  + (4.2.2)
• Reference:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007 IV  + (4.2.2)
• Reference:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 Page 3 - CRF  + (4.2.2)
• Reference:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 Page 3 - Note  + (4.2.2)
• Reference:USA FDA - HUMAN DRUG CGMP NOTES Volume 8, Number 3 6  + (4.2.2)

• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4  + (4.2.3)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.10  + (4.2.3)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 For systems used or deployed by the investigator/institution  + (4.2.3)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3  + (4.2.3)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.3  + (4.2.3)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Computerised Systems Validation  + (4.2.3)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.4  + (4.2.3)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.8  + (4.2.3)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - validation  + (4.2.3)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8 - Electronic data handling  + (4.2.3)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.2  + (4.2.3)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.4  + (4.2.3)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 ALCOA  + (4.2.3)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 CCEAT  + (4.2.3)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.6  + (4.2.3)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 A4.13  + (4.2.3)
• Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.3 (b) (6)  + (4.2.3)
• Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.10  + (4.2.3)