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- Reference:USA 45 CFR Part 160 09-Apr-2025 - +
- Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 4. +
- Reference:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 Page 3 - Note +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3 +
- Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 II +
- Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 ALCOA +
- Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.30 +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Signature +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.3 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4 +
- Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.6 +
- Reference:EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011 14 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 For systems used or deployed by the investigator/institution +
- Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.4 +
- Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.2 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.10 +
- Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.10 +
- Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.3 (b) (6) +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Computerised Systems Validation +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.4 +
- Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 A4.13 +
- Reference:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 Page 3 - CRF +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.8 +
- Reference:USA FDA - HUMAN DRUG CGMP NOTES Volume 8, Number 3 6 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - validation +
- Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 CCEAT +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Part 1 Article 2 +
- Reference:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 - +
- Reference:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 Article 3 Paragraph 10 +
- Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.8 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8 - Electronic data handling +
- Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.102 (m) +
