Assessing CDISC SDTM Compliance

Problem

You want to validate a domain for compliance with the CDISC SDTM data standard.

Solution

Use the CDISC-SDTM Compliance transformation to assess the structural and content compliance with a data standard. You can assess an individual domain or a set of domains. The process assesses whether the selected domains comply with the data standard.

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

Tasks

To assess compliance, 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 Compliance, and drag and drop it onto the diagram. The Diagram page displays the CDISC-SDTM Compliance transformation and the Results and Metrics data sets.

Note: By default, the Results and Metrics data sets are written to a temporary work location. If you want to store this information permanently, right-click on each table, and select Properties. On the Physical Storage tab, select a SAS library for the Location field.
In the diagram, double-click on CDISC-SDTM Compliance. The CDISC-SDTM Compliance Properties dialog box appears.

Note: By default, the CDISC-SDTM Compliance 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.
Click the Data Standard tab. All active SDTM data standards are displayed.
Select a data standard with which you want to check compliance. Then, click the Domains tab. The clinical components are displayed.
Expand a clinical component to view its domains. Select domains that you want to validate, or select the clinical component to select all of its domains.

Note: You can select domains from multiple clinical components.
Click the Checks tab. If no compliance checks are displayed, then click Add. The Add Compliance Check(s) dialog box appears with a list of all available compliance checks.

Note: If you imported the CDISC SDTM 3.1.2 data standard, then compliance checks for this data standard also appear in the Standard column in the Checks tab. The Standard column is displayed if you select Show details. A check that has the value CDISC-SDTM applies to both the CDISC SDTM 3.1.1 and CDISC SDTM 3.1.2 standards. A check that has the value CDISC-SDTM 3.1.2 applies to the CDISC SDTM 3.1.2 standard only.
To view more information, select Show details. Detailed information about each compliance check is displayed. Select one or more compliance checks from the list. Click Add Selected. A confirmation message is displayed. Click OK.

Note: You can select and add more than one compliance check. Select the first compliance check, and while holding down the CTRL key, select additional compliance checks.
Note: Some check IDs are listed more than once. When you select Show details, you can view information that makes the individual compliance check unique. For example, consider the check ID SDTM0001:
- In the first record, Source is Janus and Severity is Note. If the domain fails this compliance check, then the Results data set reports a note.
- In the second record, Source is WebSDM and Severity is Warning. If the domain fails this compliance check, then the Results data set reports a warning.
To be efficient, only choose a subset of the compliance checks. It is inefficient to run the same compliance checks multiple times if the only differences between the checks are severity and source.
Click OK to close the CDISC-SDTM Compliance Properties dialog box. A green checkmark next to the CDISC-SDTM Compliance transformation indicates that the transformation is completed.

Note: If you see a red X, then hover over the transformation and information about any errors will appear. A typical error is that selected domains do not have a library assigned. Correct any errors before running the job.
Click Run to run the job. 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 data sets are generated.
Review the Results data set to see the results of the compliance checks. You might want to connect the Results and Metrics data sets as input to the code that will be used to generate formatted reports of the results.

Note: You might encounter errors or warnings in the SAS log during job execution. These errors or warnings do not mean that validation was unsuccessful. Most errors that halt a validation are reported in the Results data set. As a general rule, the Results data set reports failures and provides information about the cause of the failures. For more information about validation, see the SAS Clinical Standards Toolkit: User Guide.