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• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.25 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (6) by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023) 3 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:INT ISPE - GPP Revision 3 (2015) II. by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) - by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 Annex III 1. by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Glossary by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E8 Guideline R1 (2021) 5. by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:N.A. SPIRIT 2013 - Chan et al. 2013 - by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - CIP by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 28-29 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Appendix 2 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 2 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - protocol by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) II 7.4 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) Appendix B by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:WMA Declaration of Helsinki 2024 Paragraph 22 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart G by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.57-001 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.5 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported 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 - 5.2-001 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported 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 3.5.3 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported 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 3.5.2 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported 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 3 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) Appendix C C.2.3 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) Appendix C-001 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex E-001 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.64 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.24 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.8 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.6 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.4 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart D by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.42 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.30 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart B by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.40 (b) by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.124 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.111 - §56.112 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.109 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.105 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.104 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.103 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.102 (m) by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR IRAS - Integrated Research Application System 28-Jan-2025 IRAS by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR NIHR - National Institute for Health and Care Research 28-Jan-2025 - by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 15 1. - 4. by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex VIII 1. ; 2. by file upload (1 revision)