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 Name | TrialPhase |
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Parent Elements | Protocol |
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Element XPath(s) | /ODM/Study/MetaDataVersion/Protocol/TrialPhase |
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Element Textual Value | None |
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Usage/Business Rules | - Optional
- Cardinality: 1 or more.
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Attributes | Value |
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Child Elements | (Description?) |
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Attribute | Schema Datatype or Enumeration | Usage | Definition | Business RulesRule(s) |
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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) | Required | Human-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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