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GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 unexpected adverse reaction +
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USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 III A. ; IV. +
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USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.32 - 2.1.34 +
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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 67–69 +
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