| Element Name | ReferenceData |
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| Parent |
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Element(s)| Elements | ODM |
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| Element XPath(s) | /ODM/ReferenceData |
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| Element Textual Value | None |
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| Usage | Optional |
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| Attributes | StudyOID, MetaDataVersionOID |
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| Child Elements | (ItemGroupData* |
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)| Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rules |
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StudyOID | oidref | Required | References the Study that defines the metadata for this reference data. | MetaDataVersionOID | oidref | References the MetaDataVersion (within the above Study) for this reference | 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.
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