User contributions for Gxplex admin

16 July 2026

• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E2A Guideline 1994 III E 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E2A Guideline 1994 III B. - III C. 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.2 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.1 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 Appendix 1 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 4.3 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.3 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m 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. 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (1) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (a) (3) (ii) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64 (b) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 7.2 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-002 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021 2.-001 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 16 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 32 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-002 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-001 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 41-001 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.8 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.2 - Investigator 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Investigator 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.10 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.4 - 2.5 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.2 (a) - (d) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:DEU MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung 21-Apr-2021 § 2 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 67–69 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 64 – 66 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex F 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.52 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.33 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.19 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.1 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m 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 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 III A. ; IV. 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (s) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Unexpected adverse event 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (p) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 unexpected adverse reaction 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.3 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.51 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E2A Guideline 1994 III A. 2. 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Suspected Unexpected Serious Adverse Reaction (SUSAR) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E2A Guideline 1994 III A. 1. 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E2A Guideline 1994 II A. 3. 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.2 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Suspected adverse reaction 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (n) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 8 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.2 1 revision imported current