Importing Data Standards Metadata

Problem

You want to define studies using a CDISC standard or a data standard from your company.

Solution

If you want to use a CDISC standard, use the Import Wizard to import data standard metadata from the SAS Clinical Standards Toolkit. Importing the metadata enables you to update your environment with new releases of data standards from CDISC. CDISC data standards are provided with the SAS Clinical Standards Toolkit. For more information, see the SAS Clinical Standards Toolkit: User's Guide.
If you want to use a data standard from your company, then use the SAS Clinical Standards Toolkit to define the data standard. Then, import the data standard.
Note: You must have appropriate permissions to view the Clinical Administration tree. For more information, see Adding Users to the Clinical Administrators Group.

Tasks

To import data standards metadata, complete the following steps:
  1. In SAS Data Integration Studio, display the Clinical Administration tree. Right-click Data Standards, and then select Import.
    The Import Wizard opens. The Select Metadata Source page appears.
  2. Select the metadata source to use (for example, Clinical Data Standards Toolkit). Then, click Next.
    The Default Application Server page appears if this is your first time using the Import Wizard. Select one of the application servers that are listed. If you are unsure about which application server to pick, then contact your SAS installation representative. Otherwise, the Select Data Standard Type page appears.
  3. Select the data standard type to use (for example, CDISC-SDTM). Then, click Next.
    The Select Data Standard Version page appears.
  4. Select the data standard version to use. The CDISC standards that are listed are in the form of the standard short name, followed by the standard version number. (For example, for SDTM 3.1.2, SDTM is the standard short name, and 3.1.2 is the standard version number). Each standard listing might also include a revision number that indicates the SAS Clinical Standards Toolkit version from which the standard definition was taken (for example, SDTM 3.1.1 (1.2)). Click Next.
    The Define General Properties page appears.
  5. Edit the default values.
    1. In the Name field, enter a name to replace the default name.
      Note: It is a best practice not to include spaces in the data standard name.
    2. In the Description field, edit the description. In the Formal Name field, enter a more descriptive name for the data standard. This step is optional.
    3. In the Identifier field, specify a text value that uniquely identifies the data standard in metadata. A default value is provided. The value that you enter is verified as unique before you continue.
    4. In the Type list, select a type. The values in this list are set up by your system administrator. These values are important when using the data standards metadata in the SAS Clinical Standards Toolkit. If the required type is not in the list, then you should contact your system administrator to add the type, especially if the data standard is using the SAS Clinical Standards Toolkit. For more information about adding types, see Customizing Data Standard Properties. If the data standard does not use the SAS Clinical Standards Toolkit, then any value can be selected.
    5. In the Version field, enter additional text or accept the default value.
    6. In the Vendor field, enter a vendor value. This step is optional.
  6. Click Next.
    The Verify Domain Properties page appears.
  7. Edit the domain property values. This step is optional.
    Note: Domain properties are an advanced feature in SAS Clinical Data Integration. If you are uncertain about what domain property values to select, then accept all of the default values.
  8. Click Next. The Verify Domain Column Properties page appears.
  9. Edit the domain column property values. This step is optional.
  10. Click Next.
    • If the data standard supports validation, then the Validation Library page appears. Go to step 11.
    • If the data standard does not support validation, but does support a data model, then the Verify Column Groups page appears. Go to step 13.
    • If the data standard does not support validation or a data model, then the Verify Domain Metadata page appears. Go to step 14 .
      Note: For more information about SAS libraries, see the SAS Data Integration Studio: User's Guide.
  11. On the Validation Library page, select a library or create a new library. For more information about SAS libraries, see the SAS Data Integration Studio: User's Guide.
    Note:
    • You must have appropriate permissions for the selected library. For more information about permissions, see SAS Management Console: Guide to Users and Permissions.
    • The path for the selected library must exist.
    • The library metadata object is created immediately. Even if you close the Import Model wizard, then the library will remain.
  12. Click Next.
    • If the data standard supports a data model, then the Verify Column Groups page appears. Go to step 13.
    • If the data standard does not support a data model, then the Verify Domain Metadata page appears.Go to step 14.
  13. On the Verify Column Groups page, review the column groups that are defined in the data standard. The Verify Column Groups page is refreshed with detailed information about the columns that are defined in the data standard. After you review this information, click Next.
    The Verify Domain Metadata page appears.
  14. On the Verify Domain Metadata page, review the domain templates that are defined in the data standard.
    Note: This information is provided only as a reference. It enables you to review the metadata before storing it. You cannot make changes to this information. If you see problems in the metadata, then contact whomever is responsible for registering the data standard in the SAS Clinical Standards Toolkit.
  15. Click Next.
    The Verify Domain Column Metadata page appears.
  16. On the Verify Domain Column Metadata page, review the columns that are defined in the data standard.
    Note: This information is provided only as a reference. It enables you to review the metadata before storing it. You cannot make changes to this information. If you see problems in the metadata, then contact whomever is responsible for registering the data standard in the SAS Clinical Standards Toolkit.
  17. Click Next.
    The summary page appears.
  18. On the summary page, review the summary. To make changes, click Back. To cancel the changes without saving them, click Cancel. To save the changes, click Finish.
If supported by the data standard, then domain templates, column groups, and validation data sets are displayed in the Data Standards folder in the Clinical Administration tree. For example, if you select the CDISC-SDTM data standard type and version 3.1.1, then the domain templates (SDTM domains), column groups (SDTM classes), and validation data sets (compliance checks) are displayed in a folder that is named what you entered in the Name field.
By default, an imported data standard has a status of Inactive. This status enables you or a data standards administrator to review the template and make changes before releasing it for general use. When you or the data standards administrator is satisfied with the template, you can change its status to Active. Active templates are available for general use.
To make a data standard available for general use, complete the following steps:
  1. In SAS Data Integration Studio, display the Clinical Administration tree. Expand Data Standards.
  2. Right-click the data standard that you want to activate, and select Properties.
  3. In the Data Standard Properties dialog box, click the Properties tab. In the Active field, change false to true. Click OK.
Copyright © SAS Institute Inc. All rights reserved.