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1. Select variables for the domain from the SDTM. Variables may only be selected from Gariables Selection of variables must align with SDTM Usage Restrictions.The general approach for adding variables to a domain from the SDTM is to:
   1. Include applicable Identifier variables.
   2. Include applicable Qualifier variables from in alignment with the identified SDTM General Observation ClassClasses.
   3. Include the applicable SDTM Timing variables. In general, the domain must have at least one timing variable.
   4. Apply the domain code to the variables as appropriate variables in the domain by replacing all variable prefixes (shown in the SDTM as “--“) with the domain code.
   5. Set the Set the order of variables consistent with the order defined in the SDTM for the general observation classGeneral Observation Class.
   6. 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.

   7. 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 when variables cannot be selected from the SDTM.