Pages that link to "Glossary:TAG-00045-Adv-hte"

The following pages link to Glossary:TAG-00045-Adv-hte:

Displaying 46 items.

• Glossary (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.7 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Adverse Event (AE) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.1 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.2 (a) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - adverse event (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.2 (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 32-34 (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No. 19 (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 57 – 59 (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 60 – 62 (← links)
• Reference:EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.1 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Adverse event (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Life-threatening Adverse event (← links)
• Reference:USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017) - (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 adverse event adverse reaction (← links)
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (m) (← links)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.1. (← links)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.1 (← links)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.2 (← links)
• Reference:ICH ICH E19 Guideline 2022 6 (← links)
• Reference:ICH ICH E2A Guideline 1994 II B. Serious/Severe (← links)
• Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 8 (← links)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.2 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Unexpected adverse event (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.1 (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex F (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.2 (a) - (d) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Investigator (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 41-001 (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (a) (3) (ii) (← links)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.3 (← links)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.1 (← links)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.2 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.13 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Sponsor (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.2 - Sponsor (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Committee (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 41-002 (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 1-2 (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 1 (← links)
• Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 R1123-46 (← links)
• Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; Evaluation (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 9.4 (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX III Section 2.1 (← links)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.6.6.1 (← links)