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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
Usage/Business Rules
  • Optional
  • Cardinality: 1 or more.
Attributes

Name

Child Elements(Description?)


AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rules
Name

(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.
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