Managing Controlled Terminology

Overview

SAS Clinical Data Integration enables you to manage controlled terminology. Controlled terminology is a set of possible values for something. For example, controlled terminology for the valid values of yes and no could be expressed as (1-Yes, 2-No).
A terminology table is a SAS data set that contains controlled terminology data. SAS Clinical Standards Toolkit provides CDISC terminology tables.
A terminology package is a group of terminology tables. The data standards administrator creates terminology packages. The data standards administrator manages the granularity of the terminology and the groups to which the terminologies are available. For example, the following is the granularity of the terminology and the group to which it is available:
  • a study or submission
  • the transformations that use the controlled terminology
When a new study or submission is created, the trial manager selects the terminology package to use for the study or submission. This information is used by the CDISC-SDTM compliance transformation and the SDTM to CRT-DDS transformation.
If multiple terminology data sets are specified for a study or submission, changing the order of the terminology data sets affects the order in which the terminology tables are applied during a transformation. If a controlled term is defined several times, the first value found is the value used.

Importing Terminology Packages

To manage controlled terminology, you import CDISC terminology packages from SAS Clinical Standards Toolkit.
After a terminology package is imported, you can verify that the import was successful. You can open, delete, or rename the terminology tables using SAS Data Integration Studio. For more information, see SAS Data Integration Studio: User's Guide or the SAS Data Integration Studio online Help.
You can create, rename, or change the order in which the terminology tables in the package are applied during a transformation. SAS Clinical Data Integration provides the following ways to manage terminology packages:
Note: You must have the appropriate permissions to import terminology packages. For more information, see Adding Users to the Clinical Administrators Group.

Import a Terminology Package from SAS Clinical Standards Toolkit

To import a terminology package from SAS Clinical Standards Toolkit, perform the following steps:
  1. In the Clinical Administration tree, select Data Standards, right-click, and then select Import.
    The Import Wizard appears.
    Import Wizard
  2. Select Clinical Data Standards Toolkit, and then click Next.
    The Select Data Standard Type page appears.
  3. Select the data standard terminology package to import, and then click Next.
    The Select Data Standard Version page appears.
  4. Select the data standard version to use, and then click Next.
    The Terminology Library page appears.
  5. From the SAS Library drop-down list, select the library that contains the imported terminology table, or create a library.
    For information about using the New Library Wizard, see the SAS Data Integration Studio: User's Guide or the SAS Data Integration Studio online Help.
    Note: The selected library must have the Create Metadata permission enabled.
  6. Click Next
    The Terminology Datasets Folder page appears.
  7. On the Folders tab, select the metadata folder to contain the terminology metadata, and then click Next.
    The summary page appears.
  8. Click Finish.

Create a Terminology Package

To create a terminology package, perform the following steps:
  1. In the Clinical Administration tree, select Controlled Terminology, right-click, and then select New Terminology Package.
    The New Terminology Package wizard appears.
    New Terminology Package wizard
  2. Enter a name for the new terminology package, an optional version number, and an optional description.
  3. Click Next.
    The Terminology Sets page appears.
  4. To add a terminology set, perform the following steps:
    1. Click Add.
      The Add Terminology Sets wizard appears.
      Add Terminology Sets wizard
    2. Select a SAS library or create a library, and then click Next.
      For information about creating a new library or editing a library, see the SAS Data Integration Studio: User's Guide or the SAS Data Integration Studio online Help.
      The Source Terminology Tables page appears.
    3. Select one or more tables in the library, and then click Finish.
  5. To order the data sets, select a data set on the Terminology Sets page, and then click Move Up or Move Down.
  6. Click Finish.

Edit a Terminology Package

To edit a terminology package, perform the following steps:
  1. In the Clinical Administration tree, expand Controlled Terminology.
  2. Select a terminology package, right-click, and then select Properties.
    The Controlled Terminology Properties dialog box appears.
    Controlled Terminology Properties dialog box
  3. Edit the properties.
  4. To add a terminology set, perform the following steps:
    1. Click the Properties tab, and then click Add.
      The Add Terminology Sets wizard appears.
      Add Terminology Sets wizard
    2. Select a SAS library or create a library, and then click Next.
      For information about creating a new library or editing a library, see the SAS Data Integration Studio: User's Guide or the SAS Data Integration Studio online Help.
      The Source Terminology Tables page appears.
    3. Select one or more tables in the library, and then click Finish.
  5. To order the terminology data sets, select a data set on the Properties tab, and then click Move Up or Move Down.
  6. Click OK.
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