Transforming SDTM Domains in a define.xml File

Overview

The CDISC-SDTM to CRT-DDS transformation transforms 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 or the SAS Data Integration Studio online Help.

Register a New Document File

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.
To register a new document file, perform the following steps:
  1. In the Folders tree, right-click a folder, and then select Newthen selectDocument.
    The New Document dialog box appears.
    New Document dialog box
  2. Enter a name and optional description.
  3. (Optional) Click Browse adjacent to the Location field, and then navigate to the location in which to store the document.
  4. Click Browse adjacent to the File field, and then navigate to the location of the define.xml file.
  5. Click OK.

Transform SDTM Domains into a define.xml File

To transform SDTM domains into a define.xml file that complies with the CRT-DDS standard, perform the following steps:
  1. Select Filethen selectNewthen selectJob.
    An empty job diagram appears on the Diagram page.
  2. In the Transformations tree, expand Clinical, and then drag CDISC-SDTM to CRT-DDS onto the diagram.
    CDISC-SDTM to CRT-DDS transformation on the Diagram tab
  3. Right-click CDISC-SDTM to CRT-DDS, and then select Properties.
    The CDISC-SDTM to CRT-DDS Properties dialog box appears.
    For detailed information about the Properties dialog box, see the SAS Data Integration Studio: User's Guide or the SAS Data Integration Studio online Help.
  4. Click the Domains tab.
  5. In the Available Domains by Study/Submission list, select one or more domains to include in the define.xml file.
  6. (Optional) Click the Generation tab, and perform the following steps:
    1. In the Header comment field, enter the header comment text for the define.xml file.
    2. In the Output encoding field, select an encoding.
    3. In the Output Stylesheet area, select a style sheet to use.
      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.
  7. Click OK.
  8. From the Folders tree, drag the define.xml file onto the diagram.
  9. To 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.
  10. To store CRT-DDS Results work table in a permanent location, perform the following steps:
    Note: By default, the CRT-DDS Results work table is written to a temporary work location.
    1. Right-click the Work Table icon (Work Table icon), and then select Properties.
      The Properties dialog box appears.
      For detailed information about the Properties dialog box, see the SAS Data Integration Studio: User's Guide or the SAS Data Integration Studio online Help.
    2. Click the Physical Storage tab, select a SAS library for the Location field, and then click OK.
  11. 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 work table.
  12. Review the Results work table, 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 opening 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 is located on a drive to which you do not have access. To resolve the problem, move the define.xml file.
  13. (Optional) Report on the results of the transformation.
    For information, see Reporting on the Results of a Transformation.
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