The CDISC-SDTM to CRT-DDS Transformation

Problem

You want to transform domains collected during a study. Specifically, you want to transform them from the CDISC SDTM standard format into the CRT-DDS standard format.

Solution

Use the CDISC-SDTM to CRT-DDS transformation to transform SDTM domains into a define.xml file. The define.xml file complies with the CRT-DDS standard.

Note: For detailed information about creating a job with a transformation, see the SAS Data Integration Studio: User's Guide.

Tasks

Before you can create a job that uses a define.xml file, you must register a new document file. The document file references the target define.xml file.

Note: The target define.xml file is created on the server. If you want to open the target define.xml file from the job, then the target file must be in a shared location that can be accessed from the computer on which you are using SAS Data Integration Studio. An example of a shared location is a network drive.

For more information about registering a new document file, see the SAS Data Integration Studio: User's Guide.

To transform SDTM domains into a define.xml file that complies with the CRT-DDS standard, complete the following steps:

In SAS Data Integration Studio, create a new job. Select FileNewJob. An empty job diagram is displayed on the Diagram page.
In the Transformations tree, expand Clinical, select CDISC-SDTM to CRT-DDS, and drag and drop it onto the diagram. The Diagram page displays the CDISC-SDTM to CRT-DDS transformation.
Right-click on CDISC-SDTM to CRT-DDS, and select Properties. The CDISC-SDTM to CRT-DDS Properties dialog box appears.
Click the Domains tab.

Note: Make sure that the Archive Title clinical domain property has a value so that it is displayed in the define.xml file. For more information about updating properties, see Editing Domain Properties.
In the Available Domains by Clinical Component list, select one or more domains to include in the define.xml file.
Click the Generation tab. This step is optional.
In the Header comment field, enter the header comment text for the define.xml file. This step is optional.
In the Output encoding field, select an encoding to use. This step is optional.
In the Output Stylesheet area, select a style sheet to use. This step is optional.

Note: By default, no output style sheet is used. You can use a default style sheet provided by SAS Clinical Standards Toolkit, or you can select your own style sheet.
Click OK.
In the Folders tree, drag and drop the define.xml file onto the diagram.
Connect the CDISC-SDTM to CRT-DDS transformation to the define.xml file. Drag the cursor from the output port of the transformation to the define.xml file. This action connects the define.xml file to the transformation.
By default, the CRT-DDS Results data set is written to a temporary work location. If you want to store this information permanently, right-click on the Results data set , and select Properties. Change the location on the Physical Storage tab. For detailed information about the properties dialog box, see the SAS Data Integration Studio: User's Guide.
Save and run the job. SAS Data Integration Studio generates the SAS code for transforming, and then submits the code to SAS. The CRT-DDS define.xml file is created. If a define.xml already exists in that location, then it is overwritten (if the permissions on the file allow it to be overwritten). The results are written to the CDISC-SDTM to CRT-DDS Results data set. Review the Results data set and check for errors or warnings.

You can view the define.xml file by navigating to the location where you created the document file, and then open the define.xml file with a Web browser. If the Web browser fails to open the define.xml file, and displays an error message about an invalid path, then the define.xml file must be located on a drive to which you do not have access. To resolve the problem, move the define.xml file.