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• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 III B. 3. by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 III - IV. by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Q1.2 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.4 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4 3.11.4.1 - 3.11.4.2 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 VI D. by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 6.2 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (j) by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (d) by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.5 - 6.7 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.3 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported 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 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 4 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 2 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III Section 4 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Pragraph 2 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 48 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.4 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 6 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-001 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - verification (validation) of data by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - monitor by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4 3.11.4.3 - 3.11.4.6 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 314 09-Apr-2025 § 314.50 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.8 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 3-001 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 3 – 4-001 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III Paragraph 3 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 3 – 4-001 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 57 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 56 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.6 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - case -report form (CRF) by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.2.3 - 4.2.4 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.2.1 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Data Acquisition Tool (DAT) by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Case Report Form (CRF) by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.300 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.200 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.100 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.70 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.50 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.3 (b) (5) ; (b) (7) ; (b) (8) by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:GBR The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 23-Jan-2019 - by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.8 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011 14 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 - by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 Article 3 Paragraph 10 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Part 1 Article 2 by file upload (1 revision)
• 20:44, 27 June 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Signature by file upload (1 revision)