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Element Name

StudyIntervention

Parent Element(s)StudyInterventions
Element XPath(s)/ODM/Study/MetaDataVersion/Protocol/StudyInterventions/StudyIntervention
Element Text ValueNone
Usage
  • Requirement: Mandatory
CardinalityOne or more
AttributesOID
Child ElementsDescription, Coding*



AttributeSchema Datatype or enumerationUsageDefinitionBusiness Rules
OIDoidRequiredUnique identifier for the StudyIntervention element.The OID attribute for the  StudyIntervention must be unique within the Study.


The StudyIntervention element allows to describe a study intervention (medication, treatment, therapy ...) for the clinical study.
The human-readable description is provided in the Description element. The Coding element can be used to provide a machine-readable code for the indication, for example ATC M01AE01 code for "Ibuprofen" when used as a non-steroidal antiinflammatory drug.

Example:

StudyIntervention
<StudyIntervention>
    <Description>
        <TranslatedText xml:lang="en" Type="text/plain">200 mg Ibuprofen</TranslatedText>
        <!-- The ATC code for Ibuprofen is M01AE01.
        In this example we use the international OID for "ATC", which is "1.3.6.1.4.1.18458.7.2". 
        See e.g. https://www.hl7.org/fhir/identifier-registry.html-->
        <Coding Code="M01AE01" CodeSystem="urn:oid:1.3.6.1.4.1.18458.7.2" CodeSystemName="ATC"/>
    </Description>
</StudyIntervention>

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