Element Name | ItemGroupData |
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Parent Elements | ClinicalData, ReferenceData, StudyEventData |
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Element XPath(s) | /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData /ODM/ReferenceData/ItemGroupData /ODM/ClinicalData/ItemGroupData |
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Element Textual Value | None | Usage/Business Rules |
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Attributes | ItemGroupOID, ItemGroupRepeatKeyItemGroupRepeatKey, TransactionTypeTransactionType, ItemGroupDataSeq |
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Child Elements | (ItemGroupData*, ItemData*)+, AuditRecord?, Signature?, Annotation*, ItemData*, Query* |
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Attributes:
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Usage/Business Rules | - Other Information:
- The ItemGroupOID and ItemGroupRepeatKey attributes are used together to identify a particular item group. This pair of values uniquely identifies an ItemGroup within the containing StudyEvent.
- The model supports nested and repeating item groups
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Attribute | Schema Type | Usage | Definition | Business Rules |
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ItemGroupOID | oidref | Required | Reference to an ItemGroupDef for the MetaDataVersion identified in the ClinicalData element. | ItemGroupRepeatKey | repeatKey | Conditional | A key used to distinguish between repeats of the same type of item group within a single form. | When the Repeating attribute for the ItemGroupDef is "Yes" the ItemGroupRepeatKey must be unique within the parent element. |
TransactionType | (Insert | Update | Remove | Upsert | Context) | Conditional | The TransactionType attribute need not be present in a Snapshot document. | When the FileType attribute for teh ODM is Transactional, the TransactionType must be provided. |
ItemGroupDataSeq | integer | Conditional | Unique sequence # for each ItemGroupData child element (record) in the container element. | When the parent element is ReferenceData or ClinicalData, the ItemGroupDataSeq must be provided