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The specification of each domain in this guide begins with a table describing the domain's variables (a row for each) and their associated attributes (the columns across).

The following are the attributes (columns) used in this guide to describe each domain's variables:

  • The Variable Name column specifies the name of the variable; in other words, the name of the column of the dataset (e.g., "STUDYID").
  • The Variable Label column specifies a descriptive label for the variable (e.g., "Study Identifier").
  • The Type column specifies the data type of the variable. This must be "Num" for numeric data and "Char" for character (or alphanumeric) data.
  • The Controlled Terms, Codelist, or Format column specifies any controlled terminology or formats that apply to the variable. Controlled lists are surrounded with parentheses (e.g., "(BWTESTCD)" for the BWTESTCD Controlled Terminology Codelist). When a fixed value (e.g., the value for the DOMAIN variable) applies, the available value will be displayed (e.g., "BW"). When a format applies, the name of the format will be displayed (e.g., "ISO 8601" for the ISO 8601 date format).
  • The Role column specifies the role of the variable (see Section 2.4, Observations and Variables).
  • The CDISC Notes column specifies details about the proper use of the variable (e.g., description of the variable's purpose, intended use, rules governing its population, example values).
  • The Core column specifies whether the variable is "Req" (required), "Exp" (expected), or "Perm" (permissible); (see Section 4.1.3, Core Variables).