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  1. FHIR Specification Feedback
  2. FHIR-30549

How is the relationship between LBORRES, LBSTRESC and LBSTRESN conserved

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    • Icon: Change Request Change Request
    • Resolution: Not Persuasive with Modification
    • Icon: Highest Highest
    • CDISC Mappings (FHIR)
    • 0.1.0
    • Biomedical Research & Regulation
    • Laboratory
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      The mappings in this guide do not cover all of the SDTM elements. We did not always map data elements where there was low likelihood of the data being present in 'source' systems. I.e. if the data was expected to be calculated by the sponsor, mappings weren't provided. However, we did not follow this principle consistently. We will add an explanation in the introduction noting that the mappings are not complete and why, as well as that there is some inconsistency. We will add a question for implementers to the guide seeking feedback as to whether mapping of elements that typically won't be present in source systems would be useful - i.e. whether all SDTM elements should be mapped in future releases.

      Will update the documentation on the mapping of LBORRES to say:
      "CDISC (and sponsors) may have different definitions about what constitutes an "original result".  Sponsors will need to make a determination of whether the value found in the Observation.value meets those criteria and is appropriate to be mapped.  (In some cases, what's in Observation.value could have been transformed from what was captured at the point of measurement.)"

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      The mappings in this guide do not cover all of the SDTM elements. We did not always map data elements where there was low likelihood of the data being present in 'source' systems. I.e. if the data was expected to be calculated by the sponsor, mappings weren't provided. However, we did not follow this principle consistently. We will add an explanation in the introduction noting that the mappings are not complete and why, as well as that there is some inconsistency. We will add a question for implementers to the guide seeking feedback as to whether mapping of elements that typically won't be present in source systems would be useful - i.e. whether all SDTM elements should be mapped in future releases. Will update the documentation on the mapping of LBORRES to say: "CDISC (and sponsors) may have different definitions about what constitutes an "original result".  Sponsors will need to make a determination of whether the value found in the Observation.value meets those criteria and is appropriate to be mapped.  (In some cases, what's in Observation.value could have been transformed from what was captured at the point of measurement.)"
    • Rebecca Baker/Christi Denney : 17-0-3
    • Clarification
    • Non-substantive
    • Yes

    Description

      It is not clear how the CDISC relationship between LBORRES, LBSTRESC, and LBSTRESN are concerved

      (Comment 35 - imported by: Lloyd McKenzie)

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            mrocca Mitra Rocca
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