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This page provides a simple browsing interface for finding entities described by a property and a named value. Other available search interfaces include the page property search, and the ask query builder.
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- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Adverse Event (AE) +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 79 +
- Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (l) +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.58 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.68 +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.145 +
- Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.1-002 +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Serious Adverse Event (SAE) +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.1 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.2 (a) +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - adverse event +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - serious adverse event +
- Reference:WMA Declaration of Helsinki 2024 Paragraph 23 - Oversight +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.2 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.45 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 32-34 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No. 19 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 57 – 59 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 60 – 62 +
- Reference:EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.1 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Adverse event +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Life-threatening Adverse event +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - SAE +
- Reference:USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017) - +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 adverse event adverse reaction +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 serious adverse event +
- Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (m) +
- Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (o) +
- Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.1. +
- Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.28 +
- Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.14. +
- Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.21. +
