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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).

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TrialPhase

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Element

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TrialPhase

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Element

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  • Optional
  • Cardinality: 1 or more.

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Value

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(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)

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The TrialPhase/@Name must be unique within the Study.

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