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 applicable 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 in this column are:

SEE OBSERVATIONS AND VARIABLES IN SEND SECTION 2.4

Provides additional context for the intended of the variable and may include:

• A description of the purpose of the variable and/or what the variable means. 
• Guidelines for variable use including rules for when or how the variable should be populated, or how the contents should be formatted.
• Example values which could be populated in the variable. Such values are intended to support understanding of the variable and are not intended to influence decisions regarding data to collect and subsequently represent in the variable. For guidance on the selection of data to collect, please refer to the appropriate regulatory authority.  

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

SDTM - 

• SDTM Core Designations.