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

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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