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 | ||
|---|---|---|---|
| Parent Elements | Protocol | ||
| Element XPath(s) | /ODM/Study/MetaDataVersion/Protocol/TrialPhase | ||
| Element Textual Value | None | Usage/Business Rules | |
| Attributes | Value | ||
| Child Elements | (Description?) |
(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)
The TrialPhase/@Name must be unique within the Study.
This is an extensible attribute.| Usage/Business Rules |
|---|