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An ItemGroupDef describes a type of variable or field grouping that can occur within a study.

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ItemGroupDef Element
ItemGroupDef Element

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ItemGroupDef Attributes
ItemGroupDef Attributes


Example
titleSimple ItemGroupDef

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ItemGroupDef Example - Simple
ItemGroupDef Example - Simple

Example
titleSimple ItemGroupDef

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ItemGroupDef Repeating Example
ItemGroupDef Repeating Example

Example
titleThe use of nested ItemGroupDef for representation of a Biomedical Concept

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Biomedical Concept Example: Blood Pressure
Biomedical Concept Example: Blood Pressure

Body:

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Attributes:

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Contained in:

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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.

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