Assessing ADaM Compliance

Overview: Assessing ADaM Compliance

You assess the structural and content compliance of a data set with the ADaM data standard by using the ADaM Compliance transformation. You can assess an individual data set or a set of data sets. The process assesses whether the selected data set complies with the data 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.

Assess ADaM Compliance

To assess ADaM compliance, perform the following steps:

Create an empty job.

For detailed information about creating an empty job, see the SAS Data Integration Studio: User's Guide or the SAS Data Integration Studio online Help.
In the Transformations tree, expand Clinical, and then drag and drop CDISC-ADaM Compliance onto the diagram.

The Diagram tab displays the CDISC-ADaM Compliance transformation and the Results and Metrics work tables.
(Optional) To store the Results and Metrics work tables in a permanent location, perform the following steps:

Note: By default, the work tables are written to a temporary work location.
1. Right-click each 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.
In the diagram, double-click CDISC-ADaM Compliance.

The CDISC-ADaM Compliance Properties dialog box appears.
Click the Data Standard tab.

All active ADaM data standards are displayed.
Select a data standard, and then click the Tables tab.

The studies and submissions are displayed.
Select an ADaM model and a source model.
In the ADaM Tables to Check and the Source Tables to Check lists, expand a study or submission to view its data sets.
Select the data sets to validate, or select the study or submission to select all of its data sets.

Note: You can select data sets from multiple studies and submissions.
Click the Checks tab.
If no compliance checks are displayed, perform the following steps:
1. Click Add.
  
  The Add Compliance Check(s) dialog box appears with a list of all available compliance checks.
2. Click Show details.
  
  Detailed information about each compliance check appears.
3. Select one or more checks, click Add Selected, and then click Close.
(Optional) Click the Reports tab, and perform the following steps:
1. Perform one of the following steps:
  
  Select Report by Domain and the Generate Domain Report check box
  
  Select Report by Check and the Generate Check Report check box
2. Perform one of the following steps:
  
  Click Browse adjacent to Browse to Folder, and then navigate to a server folder.
  
  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.
3. Enter a name for the report in the Report File Name field, and then specify the report output format.
4. To limit the number of records to include in the report, enter a number in the Limit # of records to field.
  
  If you leave this field blank, all records are included in the report.
5. Select the panels to include in the report and whether informational messages are included.
Click OK to close the CDISC-ADaM Compliance Properties dialog box.

A green check mark adjacent to the CDISC-ADaM Compliance transformation indicates that the transformation is complete.

Note: If you see in the lower right corner of the transformation, click and review the error information that appears. A typical error is that selected domains do not contain an assigned library. Correct any errors before running the job.
Click Run.

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 are generated.
Review the Results work table to see the results of the compliance checks.

You might want to connect the Results and Metrics work tables as input to the code 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 work table. As a general rule, the Results work table reports failures and provides information about the cause of the failures. For more information about validation, see the SAS Clinical Standards Toolkit: User Guide.