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).
/ODM/Study/MetaDataVersion/Protocol/TrialPhase
- Optional
- Cardinality: 1 or more.
Value
Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rules |
---|---|---|---|---|
Value | (PHASE 0 TRIAL, PHASE I TRIAL, PHASE I/II TRIAL, | Required | Human readable designation of the trial phase. | The TrialPhase/@Name must be unique within the Study. This is an extensible attribute. |