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Body:


Attributes:

OIDoid

Namename

Repeating(Yes | No)

IsReferenceData(Yes | No)(optional)
DatasetNamename(optional)
Domaintext(optional)
Origintext(optional)
Rolename(optional)Deprecated
Purposetext(optional)
Commenttext(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 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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