The reason for performing a study in terms of the scientific questions to be answered by the analysis of data collected during the study.
| Element Name | StudyObjective |
|---|---|
| Parent Element | StudyObjectives |
| Element XPath(s) | /ODM/Study/MetaDataVersion/Protocol/StudyObjectives/StudyObjective |
| Element Textual Value | None |
| Attributes | OID, Name, Level |
Child Elements | (Description?, StudyEndPointRef*) |
Usage/Business Rules |
| Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rule(s) |
|---|---|---|---|---|
| OID | oid | Required | Unique identifier for the StudyObjective element. | The OID attribute value must be unique within the Study/MetaDataVersion. |
| Name | name | Required | Name of the study objective | The Name attribute must be unique within the StudyObjectives elements within a Study/MetadataVersion. |
| Level | (Primary | Secondary | Exploratory) | Optional | Defined level for the Study Objective | These are defined in concordance with the ICH M11 Clinical electronic Structured Harmonised Protocol Specification |
Example
StudyObjective
<StudyObjective OID="SO.WEIGHT_LOSS" Name="Assess weight loss study objective" Type="Primary">
<Description>
<TranslatedText xml:lang="en" Type="text/plain">To assess adherence rates and the effectiveness of 4 popular diets for weight loss</TranslatedText>
</Description>
<StudyEndpointRef StudyEndpointOID="SEP.WEIGHT_LOSS"/>
</StudyObjective>