Note:
SDTM 3.1.2 and 3.1.3 standards
are supported. E2B standard domains cannot be deleted. You can add an export template that is predefined according to an FDA SDTM standard or E2B standard. This attempts to map all matching items based on the name match from the SDTM variable name to the TrialMaster item name. First the match is made on the SAS name, and next on the item caption. If there is no match, then the expression is set as an empty string. The exception to this is for the SDTM item “DOMAIN” where the expression will default to the domain in single quotes (e.g., ‘DM’ for demographics).
Note:
SDTM 3.1.2 and 3.1.3 standards
are supported. E2B standard domains cannot be deleted.
To add standard domains:
1. Access the Export Template Domains page. (See Properties of Export Templates for guidance.)
2. Click the Add Standard Domains button.
The Standard Domain Mappings dialog displays.
3. Do the following to complete the dialog:
· Select the Standard Mapping from the drop-down list.
· If you do not want the variable lengths automatically calculated, de-select the check box. (The option only applies to SDTM export templates. When creating All Forms/Groups export templates, the SAS length property of the item is automatically used as the variable length.)
· To add all domains, leave all the check boxes selected and then click the Save button.
· To select specific mappings, do one of the following:
o De-select the check box in the top left column, select the applicable check boxes, and then click the Save button.
o De-select the check boxes of the domains that you do not want to add, and then click the Save button.
The new standard domains display as new rows in the table, and a message displays at the top of the page, indicating that the domains were saved successfully. The Type column indicates the domain type is "Standard".
