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- 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)
- Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.30 + (4.2.3)
- Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.102 (m) + (4.2.3)
- Reference:USA 45 CFR Part 160 09-Apr-2025 - + (4.2.3)
- Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 II + (4.2.3)
- Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 4. + (4.2.3)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Signature + (4.2.4)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Part 1 Article 2 + (4.2.4)
- Reference:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 Article 3 Paragraph 10 + (4.2.4)
- Reference:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 - + (4.2.4)
- Reference:EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011 14 + (4.2.4)
- Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.8 + (4.2.4)
- Reference:GBR The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 23-Jan-2019 - + (4.2.4)
- Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.3 (b) (5) ; (b) (7) ; (b) (8) + (4.2.4)
- Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.50 + (4.2.4)
- Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.70 + (4.2.4)
- Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.100 + (4.2.4)
- Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.200 + (4.2.4)
- Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.300 + (4.2.4)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Case Report Form (CRF) + (4.2.5)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Data Acquisition Tool (DAT) + (4.2.5)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.2.1 + (4.2.5)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.2.3 - 4.2.4 + (4.2.5)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - case -report form (CRF) + (4.2.5)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.6 + (4.2.5)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 56 + (4.2.5)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 57 + (4.2.5)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 3 – 4-001 + (4.2.5)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III Paragraph 3 + (4.2.5)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 3 – 4-001 + (4.2.5)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 3-001 + (4.2.5)
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.8 + (4.2.5)
- Reference:USA 21 CFR Part 314 09-Apr-2025 § 314.50 + (4.2.5)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4 3.11.4.3 - 3.11.4.6 + (4.3.1)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - monitor + (4.3.1)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - verification (validation) of data + (4.3.1)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-001 + (4.3.1)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 6 + (4.3.1)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.4 + (4.3.1)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 48 + (4.3.1)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Pragraph 2 + (4.3.1)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III Section 4 + (4.3.1)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 2 + (4.3.1)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 4 + (4.3.1)
- Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - Monitoring + (4.3.1)
- Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.3 + (4.3.1)
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.5 - 6.7 + (4.3.1)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (d) + (4.3.1)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (j) + (4.3.1)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 6.2 + (4.3.2)
- Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 VI D. + (4.3.2)
