Support for custom domains began with the CDISC SEND Implementation Guide 3.1. Custom domains allow data that is not yet modelled in SEND to be defined and loaded along with other SEND data for a study. This allows for flexibility in modelling of nonclinical study data while maintaining the structured, standardized format of CDISC standards. When creating a custom domain, it's crucial to follow the SDTM (Study Data Tabulation Model) principles and any domains created must contain variables that comply with the version of SDTM used by the SEND standard being used for the overall dataset package. For more information on creating custom domains, see the SDTM resources on the CDISC website.
SEND XPT datasets with valid custom findings domains that align with SDTM V1.5 can be loaded into SEND Explorer, but there is configuration needed prior to upload. The custom domain(s) must be defined in SEND Explorer and connectors established. Only users with Data Steward or Administrator permissions can make the configuration changes needed to support custom domains.
Follow the steps below to define a custom domain.
Click on the Data Steward menu, then Domains
Click on the Create Domain button
Type in the 2-letter domain code used in the custom domain dataset (e.g. NX)
Locate the row for the newly added custom domain in the grid, click on the cell for the Display Label column and type in the long name for the domain. Add a reason for the addition and select Y from the pulldown menu.
Click on the cell for the WH Domain Ind column and select Y from the pulldown menu, provide a reason for the addition and click on the OK button.
Click on the cell for the WH Table column and type in either “ds_finding” (findings domains) or “ds_finding_qualifier” (supplemental qualifier domains), provide a reason for the addition and click on the OK button.
Click on the cell for the Custom Domain column and select Finding Measured, Finding Observed or Supplemental Qualifier from the pulldown menu based on the type of data present in the custom domain dataset, provide a reason for the addition and click on the OK button.
Follow the steps below to create connectors for a custom domain.
Click on the Data Steward menu, then Connectors.
For domains that contain the SPEC (Specimen) variable, 5 connectors will need to be added. For domains that do not contain the SPEC variable, 3 connectors will need to be added.
Click on the Create Connector button and add the connectors needed based on the table below, filling in all columns as specified. Specimen and Specimen Modifier connectors are only needed for custom domains that contain the SPEC variable.
After the domain definition and connector additions have been made, a dataset containing the defined custom domain can be uploaded into SEND Explorer. Please note that endpoints contained in custom domains can be viewed/visualized in the domain grid view and in Summary Views (Summary by Timepoint, Summary by Test Code, Summary by Tissue, Summary by Group) for measured (numeric) data.