ODM-11 - Getting issue details... STATUS An ItemGroupDef describes a type of variable or field grouping that can occur within a study.
| Element Name | ItemGroupDef |
|---|---|
| Parent Elements | MetaDataVersion |
| Element XPath(s) | /ODM/Study/MetaDataVersion/ItemGroupDef |
| Element Textual Value | None |
| Attributes | OID, Name, Repeating, IsReferenceData, Structure, ArchiveLocationID, DatasetName, Domain, Type, Purpose, StandardOID, IsNonStandard, HasNoData, CommentOID |
| Child Elements | (Description?, Class?, (ItemGroupRef?, ItemRef?)+, Coding*, WorkflowRef?, Origin*, Alias*, Leaf?) |
| Usage/Business Rules |
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| Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rule(s) |
|---|---|---|---|---|
| OID | oid | Required | Unique identifier for the ItemGroupDef element. |
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| Name | name | Required | Human readable name for the ItemGroupDef. |
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| Repeating | (No | Simple | Dynamic | Static) | Required | The Repeating attribute indicates that the ItemGroup may occur repeatedly within the containing element. Simple - the ItemGroup repeats within the containing element and is not bound in any way. Note: It is equivalent to the ODM v1.3.2 case where Repeating="Yes". Dynamic - ItemGroupData repeats based on values in a codelist. There may be multiple occurrences for some codelist items. Static - ItemGroupData repeats based on values in a codelist. Only one occurrence may happen for each codelist item. |
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| RepeatingLimit | positiveInteger | Optional | Maximum number of repeats. |
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| IsReferenceData | (Yes | No) | Optional | Specifies whether this ItemGroupDef is used for non-subject data. |
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| Structure | text | Optional | Description of the level of detail represented by individual records in the ItemGroup | |
| ArchiveLocationID | oidref | Optional | Reference to the unique ID of a leaf element that provides the actual location and file name of the data file. |
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| DatasetName | name | Optional | Name of a file containing the ItemGroupData for this ItemGroupDef. The name applies to the object itself rather then providing a mapping to a different object. |
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| Domain | text | Optional | Identifies the scope or CDISC SDTMIG/SENDIG Domain of the ItemGroup data. The domain applies to the object itself rather then providing a mapping to a different object. |
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| Type | (Form | Section | Dataset | Concept) | Required | identifies the type of data structure the ItemGroup represents. Form - a CRF for data collection. Note, ItemGroupDef Type="Form" replaces the ODM v1.x FormDef element. Section - a section within a CRF. Dataset - tabulation, analysis or operational datasets. Concept - defines a biomedical concept. |
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| Purpose | text | Optional | Purpose of the ItemGroup. |
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| StandardOID | oidref | Optional | Reference to a Standard element. |
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| IsNonStandard | Yes | Conditional | Required for ADaM, SDTM, or SEND if StandardOID is not provided. |
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| HasNoData | Yes | Optional | Used to indicate that an ItemGroupDef has no data. May be used at sponsor's discretion or if required by a regulatory authority |
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CommentOID | oidref | Optional | Reference to a CommentDef with sponsor provided information related to this ItemGroupDef. It allows annotations to the ItemGroup. |
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The Repeating attribute indicates that this ItemGroup may occur repeatedly within the containing element. Set Repeating to Simple when the ItemGroup repeats within the containing element and is not bound in any way. Repeating="Simple" is equivalent to the ODM v1.3.2 case where Repeating="Yes". Repeating values of Dynamic or Static indicate that the number of occurrences within the containing element is driven by the values in a codelist. Set Repeating to Dynamic when the ItemGroup repeats based on values in a codelist, and multiple repeats per codelist value may be created. Set Repeating to Static when the ItemGroup repeats based on values in a codelist, and only 1 repeat may occur per codelist entry.
Note, for cases where Repeating is set to Dynamic or Static, one ItemRef within the ItemGroup must include the Repeat="Yes" attribute to indicate that this variable references the codelist that establishes the Repeating behavior.
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.
In general, the Domain and Purpose attributes, as well as the Origin child element, carry information used in the submission context. The CommentOID attribute references a CommentDef element that allows annotations to the item group.
The Type attribute identifies the type of data structure the ItemGroupDef represents, including Form, Section, or Dataset. Note, ItemGroupDef Type="Form" replaces the ODM v1.x FormDef element. ODM-26 - Getting issue details... STATUS
The DatasetName, Domain, Purpose and CommentOID attributes, as well as the Origin element, could have constraints on individual ODM extensions, such as Define-XML or associated CDISC Metadata Guidelines. For example, DatasetName could be defined as sasName in Define-XML or associated CDISC Metadata Guidelines.
ODM v2.0 introduces nested ItemGroups. ItemGroupRef elements may be added to ItemGroupDef to create hierarchical data structures of arbitrary depth. Nested ItemGroupDefs can be used for enhanced re-usability of ItemGroups. They can also represent semantic relationships between items, represent items that share common behaviors such as skip logic, or to represent items that are displayed or collected together.
The Coding child element allows to associate semantics within the group. For example a LOINC panel code in the case that the ItemGroup represents a laboratory panel.
The WorkflowRef child element allows to reference to a workflow definition (WorkflowDef) for navigation within the ItemGroup when it e.g. represents a form or questionnaire (or part of it) where there is a workflow between the items or groups of items.