Add, edit, or delete a custom term

For interactive and multisource signal configurations, you create custom terms to represent a pseudo-value for a product or event. For example, you might create a custom event term called Pain and include the following MedDRA hierarchy terms in the definition of Pain:

• Facial pain
• Lip pain
• Pain in jaw
• Gingival pain

The example is for an event variable. However, you can also create custom terms for product variables.

Custom terms appear as optional values when you define a data mining run. For more information about how custom terms are used in data mining runs, see What are custom terms?

Before you begin

• The data configurations specified for the signal configuration must be present and valid.
• The values you use to define each custom term must be present in the data configurations specified for the signal configuration.
• You cannot add, edit, or delete custom terms while a signal configuration refresh is in progress.
• Custom terms must be unique within the signal configuration.
• You must refresh the signal configuration for your changes to take effect.
• You must have the Manage Signaling Terms permission to manage custom terms.

If you are working from a multisource signal configuration:

• Custom terms are shared between the multisource signal configuration and the lead configuration, as well as any other connected configurations. Modifications made in one configuration will be saved to all.
• You cannot add or delete custom terms in a multisource signal configuration if the lead configuration or any other connected configurations are undergoing a refresh.
• For changes to custom terms to take effect, you must refresh the underlying lead configuration first, then refresh the multisource signal configuration.

Add a custom term

1. In the left navigation pane, click the Signal Review icon ().
2. From the Manage Reference Data menu (), on the top right, click Manage Custom Terms.
3. On the top left, click Create Custom Term.
4. In the Name field, type a name for the custom term.

   If the name includes an invalid character, Oracle Empirica Signal replaces the character with a pound sign (#) and displays an informational message. The following characters are invalid:

   • \, /, <, :, >, |, ?, *, ”, &, and null
   • Control characters
   • Non-ASCII characters
5. From the Item variable drop-down list, select the variable type for the term; for example, Drug or Event.
6. Specify a query to identify the cases for which to include the custom term.
   • Create Using Query Wizard: Create a query from scratch following the steps of the wizard.
   • Create From Existing Query: Choose an existing query. You must have created or published the query. Subsequent changes you make to the query in the library do not affect the custom term.
7. In the Hierarchy Path field, click Select <hierarchy> term.
8. Browse the hierarchy to find the hierarchy item with which to associate the custom term.
9. Click OK.

Edit a custom term

1. In the table, locate the custom term to edit.
2. Select the custom term's Row Action menu () icon, then click Edit.
3. Edit the fields as necessary.

   Note:

   We recommend that you do not change the name of the custom term. Changing the name does not actually change the name of the custom term. Rather, it creates a new custom term and removes the old one in the next refresh. Prior comments, topic associations, and unreviewed alerts associated with the prior custom term's product-event combinations will be orphaned.
4. Click OK.

Delete a custom term

1. In the table, locate the custom term to delete.
2. Select the custom term's Row Action menu () icon, then click Delete.
3. Confirm the deletion by clicking OK.