Tables in this document include the following variable metadata:

  • Variable Name
  • Variable Label
  • Type (i.e., SAS data type, as described in Section 2.1, Model Concepts and Terms – Variables)
  • Format (an ISO format standard or a description such as "number-number")
  • Role (as defined in Section 2.1)
  • Variable(s) Qualified (for the variables with a role of Variable Qualifier or Synonym Qualifier)
  • Usage Restrictions (rules for when a variable can or cannot be used in a particular kind of trial, a particular class, or a particular domain)
  • Variable C-code (the concept code associated with a variable definition by the National Cancer Institute Enterprise Vocabulary Services (NCI-EVS))
  • Definition (published as part of CDISC Controlled Terminology through the NCI-EVS)
  • Notes (descriptive information not covered elsewhere)
  • Examples (sample values or descriptions of kinds of information used to populate the variable)

Information on usage restrictions and examples that were in the Description column in SDTM v1.x tables have been moved to the Usage Restrictions and Examples columns. Other information previously in the Description column has been moved to the Notes column, except that definition-like information has been removed for variables which have approved definitions. 

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