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- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.5 – 2.12.9 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.11 – 2.12.14 +
- Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 Introduction +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - patient/subject file +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - raw data +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8 +
- Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 94 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.47 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.48 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.5.3 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.8 +
- Reference:WMA Declaration of Helsinki 2024 Paragraph 17 +
- 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 +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 62-002 +
- Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.1-002 +
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.7 +
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 7 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 10. +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 (b) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (a) (3) +
- Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 GLOSSARY OF TERMS +
- Reference:WHO WHO - Guidance for best practices for clinical trials 2024 2.1.8 +
- Reference:WHO WHO - Guidance for best practices for clinical trials 2024 2.4 +
- Reference:WHO WHO - Guidance for best practices for clinical trials 2024 2.5 +
- Reference:WHO WHO - EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS Forty-fifth report - +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.1.4 +
- Reference:EU Eudralex - volume 4 GMP Guidelines Chapter 4 Jan-2011 4 +
- 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 +
- Reference:AUT BASG - FAQ 11-Feb-2025 Schwarz +
- Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 2. +
- Reference:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015 III +
- Reference:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007 IV +
