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Comment: Preliminary changes to page based on Team decision to allow nesting of item groups. Element and its attributes notes on the page will be adjusted in different adjustment iterations.

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Attributes:

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The Repeating flag indicates that this type of item group can occur repeatedly within the containing form (or reference data)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.

The In general, the Domain, Origin, and Purpose , and Comment attributes would carry submission information as described in the CDISC Submission Metadata Model located in the SDTM Metadata Submission and the Comment attribute allows annotations. These attributes could have constraints on individual ODM extensions like Define-XML or associated CDISC Metadata Guidelines.

Note: The Role attribute can be considered a synonym for Purpose. New applications should use Purpose rather than Role.

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