Reference data provides information on how to interpret clinical data. For example, reference data might include lab normal ranges. For a study that uses CDISC standards, reference data might include SDTM Trial Design datasets.

Element NameReferenceData
Parent ElementsODM
Element XPath(s)

/ODM/ReferenceData

Element Textual ValueNone
AttributesStudyOID, MetaDataVersionOID
Child Elements(ItemGroupData* AuditRecord?, Signature?, Annotation*)
Usage/Business Rules
  • Other Information:
    • Implementation note: Because reference data can be independent of any particular study, it may be desirable to keep the reference metadata separate from clinical metadata. This can be done by creating a Study element with no Protocol, StudyEventDef, or Type="Form" ItemGroupDef elements. All other ItemGroupDefs elements would have IsReferenceData=Yes. Such a study would have no clinical data.
AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rule(s)
StudyOIDoidrefRequiredReferences the Study that defines the metadata for this reference data.
  • Must match the OID  of a Study element with a MetaDataVersion OID attribute that matches the MetaDataVersionOID.
MetaDataVersionOIDoidrefRequired

References the MetaDataVersion (within the above Study) for this reference data.

All metadata references (OIDs) occurring within this ReferenceData element refer to definitions within the selected metadata version.

Signature elements nested within ReferenceData have no meaning, and should be ignored.

The TransactionType attribute behaves the same within ReferenceData as it does within ClinicalData.

  • Must match the OID of a MetaDataVersion within a Study element with an OID attribute that matches the StudyOID.



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