The ItemData element is used for transmission of the clinical data for an item. The model does not support repeating items within a single item group.

Element NameItemData
Parent ElementsItemGroupData
Element XPath(s)

/ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/ItemData

/ODM/ReferenceData/ItemGroupData/ItemData

/ODM/ClinicalData/ItemGroupData/ItemData

Element Textual ValueNone
AttributesItemOID, TransactionType, IsNull
Child Elements(Value*, AuditRecord?, Signature?, Annotation*, Query*)
Usage/Business Rules


AttributeSchema Type or Enumeration ValuesUsageDefinitionBusiness Rule(s)
ItemOIDoidrefRequired

Reference to an ItemDef in the MetaDataVersion identified in the ClinicalData element.

The referenced ItemDef defines the DataType of this item. 

The ItemOID attribute is used to identify a particular item definition. This value uniquely identifies an Item within the containing ItemGroup.


TransactionType(Insert | Update | Remove | Upsert | Context)

Conditional

  • Required on the ItemData element, or one of its ancestor elements, when ODM/@FileType has the value "Transactional".  
Records the TransactionType for this ItemData instance in the source system.
IsNull(Yes)

Conditional

  • If the child element ItemData/Value  is present, the IsNull attribute must not be set.
  • If IsNull is set, the child element ItemData/Value must not be present.

Flag specifying that an item's value is to be set to null.

In the interest of creating non-verbose XML instances, one should not use ItemData elements with IsNull set to "Yes" to indicate uncollected data. The better practice is to transmit only collected data.

For use cases where data traceability is important,  providing ItemData elements with IsNull="Yes" maybe be useful.

It is not necessary to provide an ItemData element with IsNull set to "Yes" in cases where the source system would not create a record.


Example: ItemData - Value versus IsNull

ItemData - Value versus IsNull
<!-- Example ItemGroupData demonstrating the use of Value and IsNull -->
<ItemGroupData ItemGroupOID="IG.HEMATOLOGY">
    <!-- Correct use: Value -->
    <ItemGroupData ItemGroupOID="IG.WBC">
        <ItemData ItemOID="IT.WBC">
            <Value>5.2</Value>
        </ItemData>
        <ItemData ItemOID="IT.WBC_UNITS">
            <Value>10*3/uL</Value>
        </ItemData>
    </ItemGroupData>
    <!-- Correct use: IsNull - Value child element must be omitted -->
    <ItemGroupData ItemGroupOID="IT.RBC">
        <ItemData ItemOID="IT.RBC" IsNull="Yes"/>
    </ItemGroupData>
    <!-- INVALID use: both "Value" and "IsNull" are present -->
    <ItemGroupData ItemGroupOID="IT.RBC">
        <ItemData ItemOID="IT.RBC" IsNull="Yes">
            <Value>5.0</Value>
        </ItemData>
        <ItemData ItemOID="IT.RBC_UNITS">
            <Value>10*6/uL</Value>
        </ItemData>
    </ItemGroupData>
</ItemGroupData>

« ItemGroupData

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