Body:
| 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 |
| Usage/Business Rules | |
| Attributes | ItemGroupOID, ItemGroupRepeatKey, TransactionType,ItemGroupDataSeq |
| Child Elements |
| AuditRecord?, Signature?, Annotation*, ItemData*, Query* |
Attributes:
...
| Attribute | Schema Type | Usage | Definition | Business Rules |
|---|---|---|---|---|
| ItemGroupOID | oidref | Required | Reference to the ItemGroupDefan ItemGroupDef for the MetaDataVersion identified in the ClinicalData element. | |
| ItemGroupRepeatKey | repeatKey | (optional)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)(optional) | 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 | (optional)Conditional | Unique sequence # for each ItemGroupData child element (record) in the container element. |
Contained in: StudyEventData,
...
Clinical data for an item group (record). The model supports nested and repeating item groups (for example, when several previous hospitalizations are reported in one history), or within reference data.
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.
Multiple Selection Using Nested ItemGoupDef
| When the parent element is ReferenceData or ClinicalData, the ItemGroupDataSeq must be provided. |