/ODM/Study/MetaDataVersion/Protocol/StudyObjectives/StudyObjective
- Optional.
- Cardinality: 1 or more
Child Elements
| Attribute | Schema Datatype or Enumeration | Usage | Definition | Business RulesRule(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. |
| TypeLevel | (Primary , | Secondary | Exploratory) | RequiredOptional | 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:
...
| 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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