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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 |
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