Element Name | StudyObjective |
---|---|
Parent Element | StudyObjectives |
Element XPath(s) | /ODM/Study/MetaDataVersion/Protocol/StudyObjectives/StudyObjective |
Element Textual Value | None |
Usage/Business Rules |
|
Attributes | None |
Child Elements | (Description?, StudyEndPointRef*) |
Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rules |
---|---|---|---|---|
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. |
Type | (Primary, Secondary) | Required | Whether the objective is a primary or secondary objective | The study protocol document usually specifies the planned set of primary and secondary study objectives. |
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>