Element Name | ItemGroupData |
---|---|
Parent Elements | ClinicalData, ReferenceData, StudyEventData |
Element XPath(s) | /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData /ODM/ReferenceData/ItemGroupData /ODM/ClinicalData/ItemGroupData |
Element Textual Value | None |
Attributes | ItemGroupOID, ItemGroupRepeatKey, TransactionType, ItemGroupDataSeq |
Child Elements | (ItemGroupData*, ItemData*)+, AuditRecord?, Signature?, Annotation*, Query*) |
Usage/Business Rules |
|
Attribute | Schema Type or Enumeration Values | Usage | Definition | Business Rule(s) |
---|---|---|---|---|
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. |
|
TransactionType | Insert | Update | Remove | Upsert | Context | Conditional
| The TransactionType attribute need not be present in a Snapshot document. | |
ItemGroupDataSeq | positiveInteger | Conditional
| Unique sequence # for each ItemGroupData child element (record) in the container element. The ItemGroupDataSeq attribute doesn’t have any other meaning than the sequence in which the items are saved and exchanged for each ItemGroupDef. It is equivalent to the observation # in a dataset. |
|
Clinical data corresponding to an ItemGroupRef defined in the active MetaDataVersion.
The ItemGroupOID and ItemGroupRepeatKey are used together to identify a particular item group. This pair of values uniquely identifies an ItemGroup within the containing StudyEvent. The ItemGroupRepeatKey is present if and only if the ItemGroupDef is repeating.
The ItemGroupDataSeq doesn’t have any other meaning than the sequence in which the items are saved and exchanged for each ItemGroupDef. It is equivalent to the observation # in a dataset.
ItemGroupData can also occur as reference data. In that case, the ItemGroupOID and ItemGroupRepeatKey pair must be unique within the reference data.
The model supports nested and repeating item groups.