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Element NameStudyObjective
Parent ElementStudyObjectives
Element XPath(s)

/ODM/Study/MetaDataVersion/Protocol/StudyObjectives/StudyObjective

Element Textual ValueNone
Usage/Business Rules
  • Optional.
  • Cardinality: 1 or more
AttributesNone

Child Elements 

(Description?, StudyEndPointRef*)
AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rules
OIDoidRequiredUnique identifier for the StudyObjective element.The OID attribute value must be unique within the Study/MetaDataVersion.
NamenameRequiredName of the study objectiveThe Name attribute must be unique within the StudyObjectives elements within a Study/MetadataVersion.
Type(Primary, Secondary)RequiredWhether the objective is a primary or secondary objectiveThe 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>


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