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  1. FHIR Specification Feedback
  2. FHIR-42070

Update to include seriousness

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    • Icon: Change Request Change Request
    • Resolution: Persuasive
    • Icon: Highest Highest
    • Adverse Event Clinical Research R4 Backport (FHIR)
    • 1.0.0-ballot [deprecated]
    • Biomedical Research & Regulation
    • AdverseEvents for Clinical Research Home Page
    • Home - 1.2 Overview - 3rd Paragraph
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      Will add the word 'seriousness' so that the sentence will be "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." 

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      Will add the word 'seriousness' so that the sentence will be "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." 
    • Peter Bomberg / Rebecca Baker : 16 - 0 - 2
    • Clarification
    • 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. 

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            bheale Bret Heale
            mhamidi Mike Hamidi
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              Updated:
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