The Class element identifies which predefined Class within the model applies to the definition of the dataset.

Element NameClass
Parent ElementsItemGroupDef
Element XPath(s)/ODM/Study/MetaDataVersion/ItemGroupDef/Class
Element Textual ValueNone
AttributesName
Child Elements

(SubClass*)

Usage/Business Rules
  • Business Rule(s):
    • One Class element is allowed for each ItemGroupDef element for a dataset that follows the CDISC SDTMIG, SENDIG, or ADaMIG.
    • For analysis datasets, if the ItemGroupDef IsNonStandard attribute is used, the Class should not be provided.

AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rule(s)
Nametext  

Conditional

  • Required when ODM/@Context="Submission"

Name of the Class

  • Text must follow CDISC Controlled Terminology for General Observation Class.
  • For analysis datasets, if the ItemGroupDef IsNonStandard attribute is used, the Class should not be provided.

« ItemGroupDef

SubClass »

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