Types of Domains

A standard domain is created from a data standard that defines the domain template. When you create a standard domain, the new domain is a copy of the domain template. You can use as many domain templates as you need. The domain templates that you use to create domains are copied into a folder. Associations in the domain template metadata associate the domain template copy in this folder to the data standard from which it originated. These associations enable you to customize the domain template copy without affecting the data standard. In addition, these associations enable you to validate the copy to determine whether any customizations in the copy do not conform to the data standard.

All standard domains within a folder must be associated with the same data standard. If you want to create a copy of the standard domain using a different version of the data standard, you must create the copy in a different folder. SAS Clinical Data Integration provides domain templates that conform to existing data standards.

After selecting the standard domain templates that you want to use, you can assign a library. The library is where the physical data is created when the job is run.

During a study, there might not be an appropriate domain template for the domain that you want to create. In this case, you can create a custom domain. The custom domain uses the data model defined by the data standard to create the appropriate columns and metadata.

For example, SDTM defines a data model that is based on creating domains from groups of columns, specifically identifiers, interventions, events, findings, and timings. SAS Clinical Data Integration generalizes the concept of grouping columns with the term column group. A column group makes up a portion of a complete table.

The key criterion for creating a custom domain is whether it is meant to hold data for interventions, events, or findings. In SAS Clinical Data Integration, interventions, events, or findings are considered conditional column groups. You can select only one conditional column group per custom domain.

In addition to selecting a conditional column group, you must specify identifiers and timing. You must also select the individual columns that you want to include in the custom domain. Some column names must be prefixed with the identifier. If you select a column that has this requirement, SAS Clinical Data Integration automatically creates the correct column name with the prefix. You can define keys and set the column order before the domain is created.

You can also create a custom domain based on an existing domain. Select an existing domain that most closely satisfies your needs, duplicate it, and then modify it as needed.