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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 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
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



  • Variable Label: A longer name for the variable  
    • This may be the same as the label in the SDTM, or it may be customized for the domain.
    • Sponsors should create an appropriate label if they include in a dataset an allowable variable not in the domain specification.
  • Type: One of the 2 SAS datatypes, "Num" or "Char".  These values are taken directly from the SDTM.
  • Controlled Terms, Codelist, or Format
    • Controlled Terms
      • As noted in the table note, an asterisk (*) indicates that the variable may be subject to controlled terminology.
        • The controlled terminology might be of a type that would inherently be sponsor-defined.
        • The controlled terminology might be of a type that could be standardized, but for which a codelist not yet been developed.
        • The controlled terminology might be terminology specified in value-level metadata.
      • The name of an external code system (e.g., MedDRA) will be listed in plain text.
    • Codelist 
      • A hyperlinked codelist name in parentheses indicates that the variable is subject to the CDISC Controlled Terminology in the named codelist.
      • Multiple hyperlinked codelist names indicate that the variable is subject to 1 or more of the named codelists from CDISC Controlled Terminology. If multiple codelists are in use for a single domain, value-level metadata would indicate where each codelist is applicable.
      • A hyperlinked codelist name and an asterisk (*) indicate that the variable is subject to either the named codelist from the CDISC Controlled Terminology or to an external dictionary. The specific dictionary is identified in the metadata.
    • Format: "ISO 8601 datetime or interval" or "ISO 8601 duration" in plain text indicates that the variable values should be formatted in conformance with that standard.
  • 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, SDTM Core Designations.


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