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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.
List of results
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Suspected Unexpected Serious Adverse Reaction (SUSAR) +
- Reference:EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.2 +
- Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 8 +
- Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (n) +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Suspected adverse reaction +
- Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.2 +
- Reference:ICH ICH E2A Guideline 1994 II A. 3. +
- Reference:ICH ICH E2A Guideline 1994 III A. 1. +
- Reference:ICH ICH E2A Guideline 1994 III A. 2. +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.51 +
- Reference:EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.3 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 unexpected adverse reaction +
- Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (p) +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Unexpected adverse event +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (s) +
- Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 III A. ; IV. +
- 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 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.1 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.19 +
