Versions Compared

Old Version 4

changes.mady.by.user Lorraine Sobson

Saved on

compared with

New Version 5

changes.mady.by.user Marcelina Hungria

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Comment: Per ODM-13, moving notes to the element and attributes tables
AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rules
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)

RequiredHuman-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.