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The TrialPhase element designates the phase of the study in the clinical trial. The values are enumerated by CDISC controlled terminology TPHASE (NCI code C66737).

Element NameTrialPhase
Parent ElementsProtocol
Element XPath(s)

/ODM/Study/MetaDataVersion/Protocol/TrialPhase

Element Textual ValueNone
Attributes

Value

Child Elements(Description?)
Usage/Business Rules


AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rule(s)
Value

(PHASE 0 TRIAL, PHASE I TRIAL, PHASE I/II TRIAL,
PHASE II TRIAL, PHASE II/III TRIAL, PHASE IIA TRIAL,
PHASE IIB TRIAL, PHASE III TRIAL, PHASE IIIA TRIAL,
PHASE IIIB TRIAL, PHASE IV TRIAL, PHASE V TRIAL,
NOT APPLICABLE)

RequiredHuman-readable designation of the trial phase.
  • The TrialPhase/@Name must be unique within the Study.
  • The values are enumerated by CDISC controlled terminology TPHASE (NCI code C66737).
    • This is an extensible attribute.

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