Choose the CDISC Standard and version that is selected by default when creating CDISC domains (“Choose the standard and terminology”).
Use the Reset to Factory Settings button to change all CDISC configuration settings back to the original values upon installation.
Specify which CDISC domains and datasets are to be generated for every analysis or create custom standards for your business requirements.
These settings control the definition and domain mappings of available standards (see “Choose the standard and terminology” and “Preview PC and PP domain data”).
Click + to add a custom standard (row is appended) or select a row to edit a definition.
Use the options on the right to define the standard (CDISC Standard, name for the standard, and version number).
Specify the domains associated with this standard.
To delete a custom standard, click the corresponding X.
Modify expressions used to create variables that belong to certain CDISC domains. Factory settings of CDISC domains in PK Submit are based on the implementation guides for SEND (3.0, 3.1, and 3.1.1) and SDTM (3.2, 3.3, and 3.4). However, if you want to modify these expressions for your use, use the tools in this tab.
Updating expressions is permitted for PC, PP, ADPC, ADPP, and ADNCA domains and datasets only.
These settings control the default variable mappings (“Terminology mapping”).
To add a custom domain or dataset, make a copy of an existing one.
Select the domain to copy.
Click +.
In the appended row, edit the name as desired.
All variables within the domain are copied over.
If you do not need all domains and datasets available, you can delete them from the configurations.
Note: Once a domain/dataset is deleted, the only way to retrieve it is to perform a factory reset of the CDISC configurations, which will erase any other changes made in this tab.
To add a new variable to a domain:
Select Add Variable Definition.
Provide the following information for the new variable.
Variable: Name
Expression: Expression used to create the data within the variable. They can be based on #C expressions or basic .NET expressions (i.e., if/thens, concatenations) or specify an existing variable to prepopulate values.
Data Type: Text or Numeric
Format: Typically left blank
Description: Used as the label for XPT
Exclude from XPT option
Permissibility: Select from Required, Expected, Permissible, Cond
If you do not need certain variables for each domain or dataset, you can delete them from the configurations.
Note: Once a variable is deleted, the only way to retrieve it is to perform a factory reset of the CDISC configurations, which will erase any other changes made in this tab.
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