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For domains based on the SDTM General Observations Classes, 

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 used when the domain is based on the SDTM General Observation Classes

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 used when the domain is based on the SDTM General Observation Classes

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