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  1. FHIR Specification Feedback
  2. FHIR-35825

The FHIR FHIRPath mapping for the AE has errors

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Details

    • Icon: Change Request Change Request
    • Resolution: Persuasive
    • Icon: Medium Medium
    • CDISC Mappings (FHIR)
    • 1.0.0
    • Biomedical Research & Regulation
    • Adverse Events
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      Correct as suggested

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      Correct as suggested
    • Rik Smithies /Smita Hastak: 12-0-2
    • Correction
    • Non-compatible
    • 1.0.0

    Description

      For the AE SDTM AETERM, the FHIR resource should have been AdverseEvent.event.CodeableConcept or if we look towards R5, it should be AdverseEvent.code.CodeableConcept

       

      Others with the same error for FHIRPath include: AEDECOD, AELLT, AELLTCD, AEPTCD, AEHLT, AEHLTCD, AEHLGT, AEHLGTCD, AESOC, AESOCCD,

       

      The FHIRPath column is incorrect. 

      Please check also the Element column for these variables.  Should these be "AdverseEvent.event" or "Condition"; and what is the difference between these? Seems like the adverse event list is a valueset of the conditions that may be adverse events.  Is this right?

      Thank  you.

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            rbaker@acc.org Rebecca Baker
            rbaker@acc.org Rebecca Baker
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              Created:
              Updated:
              Resolved: