Example 4: Domain for Standard Definitions

Use standard definitions of Tables, Programs, Data Marts, and so on to make it easier to reuse definitions and reduce the amount of work required for validation. Put standard definitions in a Domain only when you have thoroughly tested and validated them so that they are approved for reuse.

You may want to use CDISC data formats for standard Table definitions and create Programs that read from and write to those tables, for example.

You can use child Domains to organize definitions by type. For example, create a child Demography Domain to store demography-related Tables, Programs, Report Sets, and Data Marts. Create an Adverse Events Domain and an Efficacy Domain, and so on.

Figure 3-5 Standard Definitions Domain

Note:

You can create these definitions as needed in other Domains and move them to the standard definition Domain when they are ready, or you can create Application Areas and Work Areas inside these Domains for the purpose of creating and testing standard definitions.