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If a logically related grouping of data is in scope for a domain defined in this guide, but not all data can be represented using the domain variables, then data may be represented by adding variables from the SDTM to the domain or by using a Supplemental Qualifier dataset related to the domain. Prior to adding variables from the SDTM or considering a Supplemental Qualifier dataset, confirm that none of the existing domain variables will fit the need. Variables may be added to a domain and Supplemental Qualifier datasets may only be used when data are different in nature and are not in scope for variables which already exist in the domain.  

Once confirmed, determine whether adding a variable from the SDTM will fit the need. If adding a variable from the SDTM meets the need, then a Supplemental Qualifier dataset will not be implemented. Supplemental Qualifier datasets will only be implemented when data are not in scope for a variable defined in the SDTM.

When applicable, the overall process for extending a domain is as follows:

  1. Select variables for the domain from the SDTM. Selection of variables must align with SDTM Usage Restrictions. As illustrated in the following figure, the general approach for selecting variables for a custom domain is to:
    1. Include applicable Identifier variables. Identifier variables STUDYID, USUBJID, DOMAIN, and --SEQ are required in all domains based on the general observation classes. Additional Identifiers may be added as needed.
    2. Include the Topic variable from the SDTM general observation class (e.g., --TESTCD for Findings). 
    3. Include the relevant Qualifier variables from the identified SDTM general observation class.
    4. Include the applicable SDTM Timing variables. In general, the domain must have at least one timing variable.
    5. Determine the two-character domain code.
      1. The domain code add domain naming rules here
    6. Apply the domain code to the appropriate variables in the domain by replacing all variable prefixes (shown in the SDTM as “--“) with the domain code.
    7. Set the order of variables consistent with the order defined in the SDTM for the general observation class.
    8. Adjust the labels of the variables only as appropriate to convey their meaning in the context of the data in the newly created domain. Use title case for all labels.

    9. Ensure that appropriate standard variables are being properly applied by comparing their use in the custom domain to their use in related TIG domains.

  2. Place any non-SDTM variables in a Supplemental Qualifier dataset. 

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