Body:
| (Description?, Annotation*, ItemGroupRef*, ItemRef*, Concept, WorkflowRef?, Origin*, Alias*) |
Attributes:
| OID | oid | ||
| Name | name | ||
| Repeating | (Yes | No) | ||
| IsReferenceData | (Yes | No) | (optional) | |
| DatasetName | name | (optional) | |
| Domain | text | (optional) | |
| Type | (Form | Dataset | Concept | ...) | (optional) | |
| Purpose | text | (optional) | |
| CommentOID | oidref | (optional) |
Contained in:
An ItemGroupDef describes a type of item group that can occur within a study.
The Repeating flag indicates that this type of item group can occur repeatedly within the containing element.
If IsReferenceData is Yes, this type of item group can occur only within a ReferenceData element. If IsReferenceData is No, this type of item group can occur only within a ClinicalData element. The default for this attribute is No.
In general, the Domain, Origin, and Purpose attributes would carry submission information and the Comment attribute allows annotations.
The Type attribute identifies the type of data structure the ItemGroupDef represents, including Form or Dataset. For example, ItemGroupDef Type="Form" replaces the ODM v1.x FormDef element.
The DatasetName, Domain, Origin, Purpose and Comment attributes could have constraints on individual ODM extensions like, for instance, Define-XML or associated CDISC Metadata Guidelines; e.g., DatasetName could be defined as sasName in Define-XML or associated CDISC Metadata Guidelines.
ODM v2.0 introduces nested ItemGroups, and ItemGroupRef elements may be added to ItemGroupDef to create a hierarchical data structures of varying depths. These additional levels of ItemGroupDefs can be used for enhanced re-usability of ItemGroups, to represent semantic relationships between items, to represent items that share common behaviors such as skip logic, and to represent items that are displayed together.