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XML4Pharma CDISC-CORE SDTM Dataset Specializations

This page shows a number of (custom) "quality" rules that we derived from the "SDTM Dataset Specializations", and that we make available to the industry.

  • For "White Blood Count", the result must be a floating point number (or an integer)

  • When EGCAT = 'INTERPRETATION", then EGSTRESC must be of type 'text'

    • In MK (Musculoskeletal System Findings), when MKTESTCD = BMMTABDT (Brooke mMRC MMT Score), then the value of MKSTRESN must be a value between 0 and 5.

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