Reporting on CDISC SDTM Compliance

Problem

You want to run a report about the compliance of a single domain or multiple domains with the CDISC SDTM data standard. You can run a report on a domain, domains, or compliance checks.

Solution

Use the CDISC-SDTM Compliance transformation to run a report about the compliance of a single domain or multiple domains with a data standard. You can run a report on a domain, domains, or compliance checks.
Note: For detailed information about creating a job with a transformation, see the SAS Data Integration Studio: User's Guide.

Tasks

To run a report, complete the following steps:
  1. In SAS Data Integration Studio, create a new job. Select Filethen selectNewthen selectJob. An empty job diagram is displayed on the Diagram page.
  2. In the Transformations tree, expand Clinical, select CDISC-SDTM Compliance, and drag and drop it onto the diagram. The Diagram page displays the CDISC-SDTM Compliance transformation and the Results and Metrics work tables.
  3. In the diagram, double-click on CDISC-SDTM Compliance. The CDISC-SDTM Compliance Properties dialog box appears.
  4. Click the Reports tab. The reports panel appears.
  5. Select whether to Report by Domain or Report by Check.
  6. Beside the Browse to Folder field, click Browse to select a folder in which to place the report. Or, in the Server Folder field, enter the name of a server folder. The folder must be on the server and must not be a local folder.
  7. Enter a name for the report in the Report File Name field.
  8. Specify whether the report output format is HTML, PDF, or RTF.
  9. You can limit the number of records to include in the report by entering a number in the Limit # of records to field. If you leave this field blank, then all records are included in the report.
  10. Select which panels to include in the report and whether informational messages are included.
  11. Click OK to close the CDISC-SDTM Compliance Properties dialog box.
  12. Click Run to run the job. To run the job, you must have selected a data standard, at least one domain, and at least one compliance check in the CDISC-SDTM Compliance transformation. SAS Data Integration Studio generates the SAS code for validating the selected data standard model, and then submits the code to SAS. The Results and Metrics work tables (data sets) and reports are generated.
  13. Locate the report in the selected server folder and open it for review.