Page History

Specifies the data type of the variable. Values for in this column are:

• Num for numeric data
• Char for character or alphanumeric data

Specifies any controlled terminology or formats that apply to the variable. Values in this column are:

• A single, required controlled term for the variable represented by the controlled term in double quotes. This value indicates the controlled term must be populated in the variable for all records in the resulting dataset.
• Names of controlled terminology codelists with allowable terms to populate the variable. Codelist names are specified in paratheses. Multiple codelist names indicate the variable is subject to one or more of the codelists.
• Names of formats to be applied to values in the variable.

Specifies the role of the variable in the resulting dataset. Values are aligned with corresponding values for variables in the SDTM. Values in this column are:

SEE OBSERVATIONS AND VARIABLES IN SEND SECTION 2.4

Provides additional context regarding the intended use of the variable and may include:

• A description of the variable's purpose
• Guidelines for Intended use
• Rules for populating the variable in the resulting dataset 
• Examples of values which may be populated in the resulting dataset

Specifies the expectations for inclusion of the variable in the resulting dataset. Values in this column are:

• Req for variables which are required to be included in the resulting dataset.
• Exp for variables which are expected to be included in the resulting dataset.
• Perm for variables which may be permissibly included in the resulting dataset.

SEE SEND see Section 4.1.3, Core Variables