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odm_referencedata

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Recently I was asked by a customer to explain how ODM “ReferenceData” works.

As I do not use it myself a lot, I went back to the ODM v.1.3.1. specification. It states:

Reference data provides information on how to interpret clinical data. For example, reference data might include lab normal ranges”.

That's it…

ReferenceData's structure is very similar to ClinicalData's structure, except that ReferenceData has no “SubjectData”, no “StudyEventData”, and no “FormData”. It only has “ItemGroupData and ItemData”. So essentially it is transporting 2-dimensional data, i.e. tables. And I think that is also its primary usage: transport of tables between applications between about data for which there are no subjects, no visits and no forms.

So I started creating a very simple example:

  <ItemGroupData ItemGroupOID="IG.VSNORMALVALUES">
      <ItemData ItemOID="IT.DIABP" Value="80">
          <MeasurementUnitRef MeasurementUnitOID="MU.MMHG"/>
      </ItemData>
      <ItemData ItemOID="IT.SYSBP" Value="120">
          <MeasurementUnitRef MeasurementUnitOID="MU.MMHG"/>
      </ItemData>
      <ItemData ItemOID="IT.HR" Value="70">
    <MeasurementUnitRef MeasurementUnitOID="MU.BPM"/>
</ItemData>
  </ItemGroupData>
odm_referencedata.1434654732.txt.gz · Last modified: 2015/06/18 21:12 by manager