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• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.9 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Independent Data Monitoring Committee (IDMC) 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 7.2 - Sponsor 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 7.1 - Sponsor 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 5.13 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 3.13.2 (a) - (b) ; (d) - (f) by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E2A Guideline 1994 III E by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E2A Guideline 1994 III B. - III C. by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.2 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.1 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 Appendix 1 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 4.3 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.3 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; IV. by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (1) by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (a) (3) (ii) by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64 (b) by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 7.2 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-002 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021 2.-001 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 16 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 32 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-002 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-001 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 41-001 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 10.8 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 7.2 - Investigator 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 7.1 - Investigator 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 4.10 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 2.4 - 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 2.7.2 (a) - (d) by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:DEU MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung 21-Apr-2021 § 2 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 67–69 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 64 – 66 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 F 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 3.52 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 3.33 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 3.19 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 3.1 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.32 - 2.1.34 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 III A. ; IV. by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (s) by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Unexpected adverse event by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (p) 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 unexpected adverse reaction by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.3 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 3.51 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E2A Guideline 1994 III A. 2. by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Suspected Unexpected Serious Adverse Reaction (SUSAR) by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E2A Guideline 1994 III A. 1. by file upload (1 revision)