Promote Gene Studied, Variant Data, V Interpretation, and V Type

CDISC recommends promotion of the following Genomics Data Class data elements as part of USCDI v5: Gene Studied, Variant Data, Variant Interpretation, and Variant Type.


  • Promote these because genomics data inform relationships between conditions, medications, and study drugs.  
  • Having genomics data exchanged in real world data will inform observational research and perhaps lead to randomized control trials to further enlighten the science.

See the HL7 Genomics Reporting Implementation Guide and the SDTMIG v3.4, Section Genomics Findings (GF) 

Genome sequence data

Missing from this data class is the element for the raw genome sequence data itself.  This should be added. 

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