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 clinical component
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.

Problem

You want to import a SAS Clinical Standards Toolkit terminology package.

Solution

SAS Clinical Standards Toolkit provides CDISC terminology packages. You can import these terminology packages using the Import Wizard.

After a terminology table is imported, you can verify that the import was successful. You can open, delete, or rename the terminology table using SAS Data Integration Studio. For more information, see SAS Data Integration Studio: User's Guide.

You can use the New Terminology Package wizard to create new terminology packages. If you want to rename the terminology package, or change the order in which the terminology tables in the package are applied during a transformation, then use the Controlled Terminology Properties dialog box.

SAS Clinical Data Integration provides the following ways to manage your terminology packages:

Note: You must have the appropriate permissions to view the Clinical Administration tree. For more information, see Adding Users to the Clinical Administrators Group.

Tasks

Import Controlled Terminology from SAS Clinical Standards Toolkit

To import a terminology table from SAS Clinical Standards Toolkit, complete the following steps:

In the Clinical Administration tree, right-click Data Standards, and then select Import. The Import Wizard opens. The Select Metadata Source page appears.
Select Clinical Data Standards Toolkit, and then click Next. The Select Data Standard Type page appears.
Select the data standard terminology to import (for example, “CDISC-TERMINOLOGY. Click Next. The Select Data Standard Version page appears.
Select the data standard version to use. Click Next. The Terminology Library page appears.
In the SAS Library list, select the library that will contain the imported terminology table.

Note: The selected library must have the Create Metadata permission enabled.
Click Next. The Terminology Datasets Folder page appears.
In the Folders tab, select the metadata folder that will contain the terminology table. Click Next. The summary page appears.
Click Finish.

Create a New Terminology Package

To create a new terminology package, complete the following steps:

In the Clinical Administration tree, right-click Controlled Terminology, and select New Terminology Package. The New Terminology Package wizard opens. The General Information page appears.
In the Name field, enter a name for the new terminology package. In the Version field, enter the version number for the terminology package. In the Description field, enter a description. The version and description are optional. Click Next. The Terminology Sets page appears.
Click Add to add the data sets that contain the terminology tables. The Add Terminology Sets wizard opens. The Source Library page appears. For more information about the Add Terminology Sets wizard, see the SAS Data Integration Studio: User's Guide.
In the SAS Library list, select the library that contains the terminology table that you want to use. Click Next. The Source Terminology Tables page appears.
In the Tables in the library list, select the terminology table or tables that you want to add. You can add one table up to the total number of tables that appear in the list. The tables can be either imported from the SAS Clinical Standards Toolkit or they can be your own terminology tables.
Click Finish. This action exits the Add Terminology Sets wizard and returns to the New Terminology Package wizard.
Click Finish. The new terminology package is displayed in the Controlled Terminology folder.

Edit a Terminology Package

To view, change, or rename the terminology package, complete the following steps:

In the Clinical Administration tree, expand Controlled Terminology.
Right-click on the terminology package that you want to view, change, or rename, and then select Properties. The Controlled Terminology Properties dialog box appears. In this dialog box, you can rename the package, change the version number and permissions, add a description or notes, or change the order of the terminology tables, to name a few functions. Changing the order of the terminology tables affects the order in which the terminology tables are applied during a transformation.
Click OK.