Reference data provides information on how to interpret clinical data. For example, reference data might include lab normal ranges. Signature elements nested within ReferenceData have no meaning, and should be ignored.
The StudyOID and MetaDataVersionOID attributes select a particular metadata version. All metadata references (OIDs) occurring within this ReferenceData element refer to definitions within the selected metadata version.
The TransactionType attribute behaves the same within ReferenceData as it does within ClinicalData.
Note: Since 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 FormDef elements. All the ItemGroupDefs would have IsReferenceData=Yes. Such a study would have no clinical data.
| Element Name | ReferenceData |
|---|---|
| Parent Elements | ODM |
| Element XPath(s) | /ODM/ReferenceData |
| Element Textual Value | None |
| Attributes | StudyOID, MetaDataVersionOID |
| Child Elements | (ItemGroupData* AuditRecord?, Signature?, Annotation*) |
| Usage/Business Rules |
|
| Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rule(s) |
|---|---|---|---|---|
| StudyOID | oidref | Required | References the Study that defines the metadata for this reference data. |
|
| MetaDataVersionOID | oidref | Required | 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. |
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