Page History

Domain specifications in this guide may be extended in cases where...

How to Read a Domain Specification - SDTMIG v3.4 - Wiki (cdisc.org)

A domain specification table includes rows for all required and expected variables for a domain and for a set of permissible variables. The permissible variables do not include all the variables that are allowed for the domain; they are a set of variables that the SDS Team considered likely to be included. The columns of the table are:

• Variable Name
  • For variables that do not include a domain prefix, this name is taken directly from the SDTM.
  • For variables with a "--" placeholder in the SDTM, the "--" is replaced by the 2-character domain code.
• 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.

Variables in the domains should be ordered with identifiers first, followed by the topic, qualifier, and timing variables.

...