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If data are in scope for a domain dataset defined in this guide, but not all data can be represented using the domain variables, then data may be represented using in variables added to a domain from the SDTM or in a related supplemental dataset related to a domain.

The overall process for creating a custom domain is as follows:

A custom domain may only be created when data are different in nature and are not in scope for domains described in this guide. Custom domains will be used to represent logically related observations based on the scientific subject matter of the data and will not be created based on:

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