This element describes a study intervention (e.g., 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 (e.g., ATC M01AE01 code for "Ibuprofen" when used as a nonsteroidal anti-inflammatory drug).
| Element Name | StudyIntervention |
|---|---|
| Parent Elements | StudyInterventions |
| Element XPath(s) | /ODM/Study/MetaDataVersion/Protocol/StudyInterventions/StudyIntervention |
| Element Text Value | None |
| Cardinality | One or more |
| Attributes | OID |
| Child Elements | (Description, Coding*) |
| Usage/Business Rules |
| Attribute | Schema Datatype or enumeration | Usage | Definition | Business Rule(s) |
| OID | oid | Required | Unique identifier for the StudyIntervention element. | The OID attribute for the StudyIntervention must be unique within the study. |
Example: StudyIntervention
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>