About Domain Data and Metadata

After a clinical component has been created, you can create domains within that clinical component. A data standard defines the domain template that is used to create the domain. You can use as many domain templates as you want or need. The domain templates that you use to create domains are copied into a folder. Associations in the domain template metadata bind the domain template copy in this folder to the data standard from which it was 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 break the conformance to the data standard.

After selecting the 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.

Instead of basing a custom domain on an existing domain template, you can choose to base it on the underlying data standard. 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. If a data standard does not have column groups, then creating a custom domain is not possible.

The key criterion for creating a custom domain is whether it is meant to hold intervention, event, or findings data. In SAS Clinical Data Integration, interventions, events, or findings are considered a conditional column group. From all conditional column groups, you can select only one per custom domain. In addition to selecting a conditional column group, you must specify identifiers and timing.

Next, you 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. The New Custom Domain wizard enables you to define keys and set the column order before the domain is created.

If you have a domain that almost meets your needs, then you can create a new domain using the existing domain as a template.