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."