Page History

...

1. Establish a common topic or topics for the data. The common topic or topics will reflect a collection of logically related observations based on the scientific subject matter of the data.
   1. If more than one topic is identified, then more than one domain may be needed.
      1. In such cases, consider whether topics are hierarchical in nature where data for one topic must be observed before data for a second topic can be observed. If a hierarchical relationship between topics exists, then a paired domains will be created (an example of an established domain pair is Pharmacokinetics Concentrations (PC) and Pharmakinetics Parameters (PP)). Records in paired domains may then be represented in the Related Records (RELREC) dataset as appropriate.
2. Categorize data within the domain using Grouping Qualifier variables (e.g., --CAT, --SCAT) and identify other qualifiers applicable to the data (e.g., --METHOD, --SPEC) as appropriate.
3. Look for a domain within this guide to serve as a prototype. If no domain seems appropriate, choose the general observation class in the SDTM (Interventions, Events, or Findings) that best fits the data given the topic of the observations.
4. Select variables for the domain from the SDTM. Section of variables must align with SDTM guidance. As illustrated in the following figure, the general approach for selecting variables for a custom domain is:
   1. Include applicable Identifier variables. Identifier variables STUDYID, USUBJID, DOMAIN, and --SEQ are required in all domains based on the general observation classes. Additional Identifiers may be added as needed.
   2. Include the Topic variable from the SDTM general observation class (e.g., --TESTCD for Findings). 
   3. Include the relevant Qualifier variables from the identified SDTM general observation class.
   4. Include the applicable SDTM Timing variables. In general, the domain must have at least one timing variable.
   5. Determine the two-character domain code.
      1. The domain code add domain naming rules here
   6. Apply the domain code to the appropriate variables in the domain by replacing all variable prefixes (shown in the SDTM as “--“) with the domain code.
   7. Set the order of variables consistent with the order defined in the SDTM for the general observation class.
   8. Adjust the labels of the variables only as appropriate to properly convey the meaning in the context of the data being submitted in the newly created domain. Use title case for all labels.

   9. Ensure that appropriate standard variables are being properly applied by comparing their use in the custom domain to their use in the TIG domains.

   10. Place any non-SDTM variables in a Supplemental Qualifier dataset. 

...