There is no differentiation of SUBJID and USUBJID

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    • Type: Change Request
    • Resolution: Persuasive
    • Priority: Highest
    • CDISC Mappings (FHIR)
    • 0.1.0
    • Biomedical Research & Regulation
    • Demographics
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      The mapping for USUBJID is different. Could express multiple alternatives.  Simplest way is to drive this off of patient.  Bring it across, then anonymize OR bring it across to generate a unique identifier. 

       

      The only way to  map across studies would be to map to patient.  Will add text to highlight some of the considerations around this like the identifiers on patient may not be appropriate to research submission use and may require anonymization/obfuscation prior to submission.

       

       

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      The mapping for USUBJID is different. Could express multiple alternatives.  Simplest way is to drive this off of patient.  Bring it across, then anonymize OR bring it across to generate a unique identifier.    The only way to  map across studies would be to map to patient.  Will add text to highlight some of the considerations around this like the identifiers on patient may not be appropriate to research submission use and may require anonymization/obfuscation prior to submission.    
    • Rebecca Baker/Christi Denney : 19-0-6
    • Correction
    • Non-substantive

      There is no differentiation of SUBJID and USUBJID. This differentiation in CDISC helps drive multiple records per patient. For example, a single patient may have multiple adverse events and thus a single USUBJID may indicate multiple SUBJID. This concept is not present in the mapping and there is not clarity on how to separate multiple files per patient.
      There are concepts in each of the domain mappings where seemingly identical concepts are mapped
      • Study Identifier
      • Site Identifier
      • Subject Identifier

      Existing Wording:

      Subject ID for the Study

      (Comment 23 - imported by: Lloyd McKenzie)

        1. image-2021-01-29-11-44-28-438.png
          image-2021-01-29-11-44-28-438.png
          17 kB

            Assignee:
            Unassigned
            Reporter:
            mrocca
            Watchers:
            2 Start watching this issue

              Created:
              Updated:
              Resolved: