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changes.mady.by.user Jozef Aerts

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Element(s)
Element Name

StudyIntervention

Parent ElementsStudyInterventions
Element XPath(s)/ODM/Study/MetaDataVersion/Protocol/StudyInterventions/StudyIntervention
Element Text ValueNoneUsageRequirement: Mandatory
CardinalityOne or more
AttributesOID
Child Elements(Description, Coding*)
AttributeSchema Datatype or enumerationUsageDefinitionBusiness RulesOIDoidRequiredUnique 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:

...

Usage/Business Rules