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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 NameStudyObjective
Parent ElementStudyObjectives
Element XPath(s)

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

Element Textual ValueNone
AttributesOID, Name, Level

Child Elements 

(Description?, StudyEndPointRef*)

Usage/Business Rules


AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rule(s)
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.
Level(Primary | Secondary | Exploratory)OptionalDefined level for the Study ObjectiveThese 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>

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