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changes.mady.by.user Lex Jansen

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changes.mady.by.user Alana St. Clair

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AttributeSchema Datatype or EnumerationUsageDefinitionBusiness RulesRule(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.
TypeLevel(Primary , | Secondary | Exploratory)RequiredOptionalWhether the objective is a primary or secondary objectiveDefined level for the Study ObjectiveThese are defined in concordance with the ICH M11 Clinical electronic Structured Harmonised Protocol SpecificationThe study protocol document usually specifies the planned set of primary and secondary study objectives.