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Key

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Element NameClinicalData
Parent ElementsODM
Element XPath(s)

/ODM/ClinicalData

Element Textual ValueNone
Usage/Business Rules
Attributes

StudyOID, MetaDataVersionOID

Child Elements

(SubjectData*, ItemGroupData*,

 

AuditRecord?, 

Signatures*

Signature?, Annotation*,

ItemGroupData*,

Query*)

Attributes:

...

The StudyOID and MetaDataVersionOID attributes select a particular metadata version. All metadata references (OIDs) occurring within this ClinicalData element refer to definitions within the selected metadata version.

...

Usage/Business Rules
  • Other Information:
    • The child element SubjectData will mostly be used when the data represents data with, for example, visits and forms, and the information is grouped per subject. The child element ItemGroupData will mostly be used for tabular data, and where the subject information can be in one of the columns of the tables, and the information is not grouped per subject.
    • The ClinicalData element can contain a mixture of data grouped per subject; that is, using SubjectData as well as data that is not grouped per subject (e.g., tabular data), using ItemGroupData.

See Section 2.7, Clinical Data Keys, for a visualization of these possibilities.