Details
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Change Request
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Resolution: Persuasive
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Highest
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Adverse Event Clinical Research R4 Backport (FHIR)
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1.0.0-ballot [deprecated]
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Biomedical Research & Regulation
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AdverseEvents for Clinical Research Home Page
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Home - 1.2 Overview - 3rd Paragraph
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Peter Bomberg / Rebecca Baker : 16 - 0 - 2
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Clarification
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Non-substantive
Description
Please update the last sentence from "These events are characterized by the need to capture cause-and-effect (although they might not be known at the time of the event), severity, and outcome." to "These events are characterized by the need to capture cause-and-effect (although they might not be known at the time of the event), seriousness, severity, and outcome."
Adding "seriousness" which is an essential qualifier that differentiates AEs vs. SAEs.