Details
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Change Request
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Resolution: Persuasive with Modification
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Low
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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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FDA Additional Seriousness Criteria CodeSystem [deprecated]
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Michelle Casagni / Rebecca Baker : 13 - 0 - 0
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Enhancement
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Non-substantive
Description
Where did the FDA Additional Seriousness Criteria CodeSystem for "requiresPreventImpairment" get used in this IG? There's a mention this is generally used as a post-market surveillance measure via FDA MedWatch 3500A.
Attachments
Issue Links
- relates to
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FHIR-42088 Several updates associated with FHIR IG R4 Backport & R5
- Published
- mentioned in
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