| Element Name | KeySet |
|---|---|
| Parent Elements | Association |
| Element XPath(s) | /ODM/Association |
| Element Textual Value | None |
| Attributes | StudyOID, SubjectKey, MetaDataVersionOID, StudyEventOID, StudyEventRepeatKey, ItemGroupOID, ItemGroupRepeatKey, ItemOID |
| Child Elements | None |
| Usage/Business Rules |
| Attribute | Schema Type or Enumeration Values | Usage | Definition | Business Rule(s) |
|---|---|---|---|---|
| StudyOID | oidref | References the StudyOID in an ODM/ClinicalData element. |
| |
| SubjectKey | subjectKey | Optional | Reference to a SubjectKey attribute value for a SubjectData child element of this ClinicalData element. |
|
| MetaDataVersionOID | oidref | Optional | Reference to a MetaDataVersionOID attribute value for this ClinicalData element. |
|
| StudyEventOID | oidref | Optional | Reference to a StudyEventOID attribute value for a StudyEventData child element of this ClinicalData/SubjectData element. |
|
| StudyEventRepeatKey | repeatKey | Optional | Reference to a StudyEventRepeatKey attribute value for a StudyEventData child element of this ClinicalData/SubjectData/StudyEventData element. |
|
| ItemGroupOID | oidref | Optional | Reference to an ItemGroupOID attribute value for an ItemGroupData child element of this ClinicalData/SubjectData/StudyEventData element. |
|
| ItemGroupRepeatKey | repeatKey | (Optional | Reference to an ItemGroupRepeatKey attribute value for an ItemGroupData child element of this ClinicalData/SubjectData/StudyEventData element. |
|
| ItemOID | oidref | Optional | Reference to an ItemOID attribute for an ItemData child element of this ClinicalData/SubjectData/StudyEventData/ItemGroupData element. |
|
A KeySet references a single entity: a study, a subject, a study event, etc. Only the attributes needed to specify the particular entity are required, and all others must be omitted. (See the section on Clinical Data Keys.)