Page History

...

When determining which general-observation class domain model is appropriate for reporting specific observations, refer to the domain definition included in the Assumptions section for each domain model (see Section 6, Domain Models Based on the General Observation Classes).

SDTM Datasets and Domains:

The SDTM lists only the name, label, and type, with a set of brief CDISC guidelines that provide a general description for each variable.

A custom domain may only be created if the data are different in nature and do not fit into an existing published domain. If data cannot be represented in a dataset defined in this guide, then a custom dataset may be used. It is recommended that a specification with the dataset name, record structure, and a domain table specification be drafted prior to support implementation, but this is not required. 

...