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Filter<p>The <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Help:Property_page/Filter">search filter</a> allows the inclusion of <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Help:Query_expressions">query expressions</a> such as <code>~</code> or <code>!</code>. The selected <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Query_engine">query engine</a> might also support case insensitive matching or other short expressions like:</p><ul><li><code>in:</code> result should include the term, e.g. '<code>in:Foo</code>'</li></ul><ul><li><code>not:</code> result should to not include the term, e.g. '<code>not:Bar</code>'</li></ul>

Showing 20 pages using this property.

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USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Adverse event +

5.1.1 +

USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Life-threatening Adverse event +

5.1.1 +

USA 21 CFR Part 312 09-Apr-2025 § 312.32 - SAE +

5.1.1 +

USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017) - +

5.1.1 +

G

GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 adverse event adverse reaction +

5.1.1 +

GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 serious adverse event +

5.1.1 +

GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (m) +

5.1.1 +

GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (o) +

5.1.1 +

U

USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.1. +

5.1.1 +

USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.28 +

5.1.1 +

USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.14. +

5.1.1 +

USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.21. +

5.1.1 +

USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.1 +

5.1.1 +

USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.2 +

5.1.1 +

I

ICH ICH E19 Guideline 2022 6 +

5.1.2 +

ICH ICH E6 Guideline R3 (2025) GLOSSARY - Adverse Drug Reaction (ADR) +

5.1.3 +

ICH ICH E2A Guideline 1994 II B. Serious Adverse Event or Adverse Drug Reaction +

5.1.3 +

ICH ICH E2A Guideline 1994 II B. Serious/Severe +

5.1.3 +

W

WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - adverse reaction +

5.1.3 +

E

EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.2 +

5.1.3 +

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