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AttributeSchema Datatype or EnumerationUsageDefinitionBusiness
Rules
Rule(s)
ItemGroupOIDoidrefRequiredReference to the ItemGroupDef.
  • Must match the OID atttribute for
a
  • an ItemGroupDef in the Study/MetaDataVersion.
MethodOIDoidrefOptional

Reference to a MethodDef that will provide one or more data rows as output.

The MethodDef is used to prepopulate items

  • The MethodOID value must match the OID attribute for a MethodDef in this Study/MetaDataVersion.
Mandatory(Yes | No)Required
Indicator of whether this ItemGroup must appear in the study clinical data for each subject per the study protocol

The Mandatory flag indicates that the clinical data for an instance of the containing event or ItemGroup would be incomplete without an instance of this type of ItemGroup. ODM clinical data files that are incomplete in this sense may be considered incomplete for study review and analysis purposes.

  • When the value is Yes, the data for each subject in the study must include a StudyEventData element with this StudyEventOID.
OrderNumber
integer
positiveIntegerOptional

Indicates the order in which this

ItemGroupDef

ItemGroup appears in Metadata displays or data entry applications.

OrderNumber must be a positive integer.

The OrderNumber attribute provides an ordering on the ItemGroupDefs (within StudyEventDef or ItemGroupDef) for use whenever a list of ItemGroupDefs is presented to a user. Order of execution is preferably defined in a workflow (see Section 3.2.2.1.8, WorkflowDef) but when used without a workflow, may be used the define the order in which data entry forms are presented in an application UI. 

  • The StudyEventRefs within a StudyEventGroup must not have duplicate OrderNumber values
CollectionExceptionConditionOIDoidrefOptional

Reference to a ConditionDef

If the CollectionExceptionConditionOID attribute is provided, the ConditionDef it references describes the circumstances under which data for this ItemGroup should not be collected.

  • The CollectionExceptionConditionOID value must match the OID attribute for a ConditionDef in this Study/MetaDataVersion