Details
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Change Request
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Resolution: Persuasive with Modification
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Highest
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FHIR Core (FHIR)
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R5
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Patient Care
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AdverseEvent
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Element Id = AdverseEvent
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Emma Jones / Stephen Chu : 5-0-2
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Clarification
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Non-substantive
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R5
Description
The long definition is okay.
The current short definition, for Adverse Event covers healthcare adverse events and not research adverse events: "Medical care, research study or other healthcare event causing physical injury".
In clinical research, after the study drug is administered, any new condition is considered an "adverse event" regardless of the relationship of the study drug. The drug is not unblinded to the patient or the research staff in some cases in large randomized blinded clinical trials.
Consider a broader definition: "An unfavorable event that occurred or may have potentially occurred that may or may not be related to medical treatment or procedure."
Attachments
Issue Links
- relates to
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FHIR-38909 Adverse Event Definition
- Resolved - No Change