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The CDISC SDTM can be implemented for tobacco product studies using the domain specifications in the following sections:

All specifications begin with the name of the domain and the expected record structure for the resulting dataset.

A domain specification table to describe the domain's variables and their attributes follows the domain name and record structure. Each table includes rows for all required and expected variables for a domain and for a set of permissible variables. There is one row for each variable with columns to describe expected attributes of the variable in resulting datasets. The columns in a domain specification table are:

Specification Table ColumnPurpose
Variable NameSpecifies the name of the name of the variable which will be the name of the column in the resulting dataset.
Variable LabelSpecifies a descriptive label for the variable. 
Type

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

  • Num for numeric data
  • Char for character or alphanumeric data
Controlled Terms, Codelist, or Format

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.
Role

Specifies the role of the variable in the resulting dataset. Values in this column are:

SEE OBSERVATIONS AND VARIABLES IN SEND SECTION 2.4

CDISC Notes

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

  • A description of the purpose of the variable and/or what the variable means. 
  • Guidelines for intended use of the variable including rules for when or how the variable should be populated, or how the contents should be formatted.
  • Example of values that may be populated in the variable. 
  • Examples of values that might appear in the variable. Such examples are only examples, and although they may be CDISC Controlled Terminology values, their presence in a CDISC Note should not be construed as definitive.
Core

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 - 




  • Role: This is taken directly from the SDTM. Note that if a variable is either a Variable Qualifier or a Synonym Qualifier, the SDTM includes the qualified variable, but SDTMIG domain specifications do not.
  • CDISC Notes may include any of the following:
    • A description of what the variable means
    • Information about how this variable relates to another variable
    • Rules for when or how the variable should be populated, or how the contents should be formatted
    • Examples of values that might appear in the variable. Such examples are only examples, and although they may be CDISC Controlled Terminology values, their presence in a CDISC Note should not be construed as definitive. For authoritative information on CDISC Controlled Terminology, consult https://www.cancer.gov/research/resources/terminology/cdisc.
  • Core: Contains 1 of the 3 values—"Req", "Exp", or "Perm"—explained further in Section 4.1.5, 


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