Page History

If a logically related grouping of data is in scope for a domain defined in this guide but not all data can be represented using the domain variables, then data may be represented by adding variables from the SDTM to the domain or by using a Supplemental Qualifier dataset related to the domain.

Jira
showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-793

Prior to adding variables from the SDTM or considering a Supplemental Qualifier dataset,

Jira
showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-794

confirm that none of the existing domain variables will fit the need. Variables may be added to a domain and Supplemental Qualifier datasets may only be used when data are different in nature and are not in scope for existing domain variables.  

Once confirmed, determine whether adding a variable from the SDTM will fit the need. If adding a variable from the SDTM meets the need, then a Supplemental Qualifier dataset will not be implemented.

Jira
showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-615

Supplemental Qualifier datasets will only be implemented for domains when data are not in scope for a variable defined in the SDTM. 

...