Revisit sex mapping

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    • Type: Change Request
    • Resolution: Persuasive with Modification
    • Priority: Highest
    • CDISC Mappings (FHIR)
    • 0.1.0
    • Biomedical Research & Regulation
    • Demographics
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      1. We will remove the explicit mapping to Patient.gender for DM.sex.  Instead, we will just have a mapping note.  The proposed mapping note text is:

       

      Sex and gender are multi-faceted.concepts. Both FHIR and CDISC standards have a large degree of ambiguity in their definitions for their primary data elements describing a subject’s sex or gender (DM.SEX and Patient.gender).  This ambiguity often exists in original source systems. Depending on the use case, the Various facets of sex and gender may be utilized or captured within clinical data..  - physiologic, social, chromosomal, etc.  As such, it's not advisable to indicate a mapping where all the facets of sex and gender are ambiguous in both the source and study data standards.  Study sponsors and regulators will need to establish policies and look into the quality and nature of the source data as well as the analysis that needs to be performed to determine appropriate mappings. 

      a) Extensions such as US core "birth sex" and FHIR core "gender identity" may give more semanticly consistent values, but may not be widely populated

      b) Some gender concepts such as physiologic and genetic characteristics may be captured as Observation values rather than as demographics elements on Patient

       

      2. In the 'contributors' portion of the implementation guide, we will add a note saying:

      "Various individuals from governmental regulatory agencies were involved in mapping discussions and in review of this document prior to publication.  Their participation in no way represents policy with respect to expectations around the submission or conversion expectations for real world data or other potential uses of these mappings."

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      1. We will remove the explicit mapping to Patient.gender for DM.sex.  Instead, we will just have a mapping note.  The proposed mapping note text is:   Sex and gender are multi-faceted.concepts. Both FHIR and CDISC standards have a large degree of ambiguity in their definitions for their primary data elements describing a subject’s sex or gender (DM.SEX and Patient.gender).  This ambiguity often exists in original source systems. Depending on the use case, the Various facets of sex and gender may be utilized or captured within clinical data..  - physiologic, social, chromosomal, etc.  As such, it's not advisable to indicate a mapping where all the facets of sex and gender are ambiguous in both the source and study data standards.  Study sponsors and regulators will need to establish policies and look into the quality and nature of the source data as well as the analysis that needs to be performed to determine appropriate mappings.  a) Extensions such as US core "birth sex" and FHIR core "gender identity" may give more semanticly consistent values, but may not be widely populated b) Some gender concepts such as physiologic and genetic characteristics may be captured as Observation values rather than as demographics elements on Patient   2. In the 'contributors' portion of the implementation guide, we will add a note saying: "Various individuals from governmental regulatory agencies were involved in mapping discussions and in review of this document prior to publication.  Their participation in no way represents policy with respect to expectations around the submission or conversion expectations for real world data or other potential uses of these mappings."
    • Correction

      The DM.SEX to patient.gender ambiguate concepts of sex and it is not clear which will end up in patient.gender. o Description = "Sex"
       FHIR Resource and Attribute chosen are Patient and gender, respectively
       FHIR Comments indicate the following "Note that gender represents the gender for administrative purposes. Genetic, physiologic, social and other gender aspects are captured as Observations"
       CDASH Variable chosen is SEX
       CDASH Mapping Instructions & Description indicates that this is the "Sex of the subject as determined by the investigator."
       SDTM Variable chosen is SEX
       SDTM Mapping Instructions & Description indicates "The corresponding CDASH Variables(s) map directly to identified SDTM Variables(s).
       SDTM definition for "SEX" is as follows: "The assemblage of physical properties or qualities by which male is distinguished from female; the physical difference between male and female; the distinguishing peculiarity of male or female. (NCI)"
       Each of the values within the codelist for the variable "SEX" in the SDTM Controlled Terminology describes physiological (i.e., biological) nature of sex distinctions, but also includes those of "cultural gender role distinctions, or both"

      Existing Wording:

      Note that gender represents the gender for administrative purposes. Genetic, physiologic, social and other gender aspects are captured as Observations

      (Comment 22 - imported by: Lloyd McKenzie)

            Assignee:
            Unassigned
            Reporter:
            mrocca
            Watchers:
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              Created:
              Updated:
              Resolved: