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Showing 20 pages using this property.
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GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 adverse event adverse reaction +
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GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 serious adverse event +
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GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (m) +
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GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (o) +
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USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.1. +
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USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.28 +
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USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.14. +
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USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.21. +
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USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.1 +
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USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.2 +
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ICH ICH E19 Guideline 2022 6 +
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ICH ICH E6 Guideline R3 (2025) GLOSSARY - Adverse Drug Reaction (ADR) +
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ICH ICH E2A Guideline 1994 II B. Serious Adverse Event or Adverse Drug Reaction +
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ICH ICH E2A Guideline 1994 II B. Serious/Severe +
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WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - adverse reaction +
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EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.2 +
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GBR MEDDEV 2.7/3 revision 3 May-2015 8 +
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GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (n) +
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USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Suspected adverse reaction +
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USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.2 +
EN  +
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