Managing Controlled Terminology :: SAS(R) Clinical Data Integration 2.6: User's Guide

Overview: Managing Controlled Terminology

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 CDISC-Define Creation 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 Data Sets

To manage controlled terminology, you import CDISC terminology data sets from SAS Clinical Standards Toolkit. A wizard imports the controlled terminology and creates the associated terminology data set.

After a terminology data set is imported, you can verify that the import was successful. You can open, delete, or rename the terminology data sets 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 data set are applied during a transformation.

Import a Terminology Data Set

To import a terminology data set, perform the following steps:

In the Clinical Administration tree, select NewTerminology Data Set.

The New Terminology Dataset wizard appears.
Select the terminology standard data set to import, and then click Next.

The Terminology Version page appears.
Select the terminology version to use, and then click Next.

The Terminology Data Set Name page appears.
(Optional) Enter a name and description, and then click Next.

The Terminology Data Sets Folder page appears.
Select the folder in which to create the terminology data set, and then click Next.

The Terminology Library page appears.
From the SAS Library drop-down list, select the library that contains the imported terminology table or create a library, or click New to create one.

For information about using the New Library Wizard to create a library, see the SAS Data Integration Studio: User's Guide or the SAS Data Integration Studio online Help.

Note: The selected library must have Create permission for the user who is currently logged on.
Click Next

The Summary page appears.
Click Finish.

Create a Terminology Package

To create a terminology package, perform the following steps:

In the Clinical Administration tree, select Terminology Packages, right-click, and then select New Terminology Package.

The New Terminology Package wizard appears.
Enter a name, an optional version number, and an optional description.
Click Next.

The Terminology Sets page appears.
To add a terminology set, perform the following steps:
1. Click Add.
  
  The Add Terminology Sets wizard appears.
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.
To order the data sets, select a data set on the Terminology Sets page, and then click Move Up or Move Down.
Click Finish.

Edit a Terminology Package

To edit a terminology package, perform the following steps:

In the Clinical Administration tree, expand Terminology Packages.
Select a terminology package, right-click, and then select Properties.

The Controlled Terminology Properties dialog box appears.
Edit the properties.
To add a terminology set, perform the following steps:
1. Click the Properties tab, and then click Add.
  
  The Add Terminology Sets wizard appears.
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.
To order the terminology data sets, select a data set on the Properties tab, and then click Move Up or Move Down.
Click OK.

Managing Controlled Terminology