The TrialPhase element designates the phase of the study in the clinical trial.

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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