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If a logically related grouping of data are 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 in variables added to a domain by adding variables from the SDTM to the domain or in by using a 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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Prior to creating a custom domainPrior to adding variables from the SDTM or considering a supplemental dataset, confirm that none of the existing published domains domain variables will fit the need.

Once confirmed, drafting a specification upfront, using determining attributes for the variable upfront per the SDTM and the conventions in Section x.x, How to Read Domain Specifications, or guidance in for supplemental datasets in <Section for supplemental qualifiers here> is recommended to ensure expectations for the custom domain data representation are clear.  Custom domains and corresponding specifications must be created based on the three general observation classes, Interventions, Events, and Findings, described in the SDTM. In most cases, the choice of observation class appropriate to a specific collection of data can be easily determined according to descriptions of these classes in the SDTM. The majority of data, which typically consists of measurements or responses to questions, usually at specific visits or time points, will fit the Findings general observation class. 

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