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- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 6.4 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 3.1 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 52 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR Guidance - Good clinical practice for clinical trials 16-Oct-2015 - by file upload (1 revision)
- 13:50, 16 July 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 - ComCompliance by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.9.3 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.119 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.70 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 12.3 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.12 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.110 (b) by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.46 (a) by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.53 (c) (vi) - (vii) by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 6. by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-003 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.6 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidance for best practices for clinical trials 2024 3.2.4 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - Introduction by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 2.5 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.5 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Compliance (in relation to trials) by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.140 (a) (2) by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.110 (c) by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.69 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.62 (a) by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.61 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.53 (b) by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.40 (c) (d) by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.6 - ยง312.8 ; ยง 312.10 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.3 (r) by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.3 (m) by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 ยง 812.3 (g) by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 50 09-Apr-2025 ยง 50.3 (j) by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 12. by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 7 Part 2 2. by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 investigational medicinal product by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 69 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 68 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 67 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 66 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 51 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.4.3-001 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.9 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - medical device-002 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 10.4 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 10.3 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.6 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.3.2 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.3 by file upload (1 revision)
- 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4.5.3 by file upload (1 revision)