Adding, editing, or deleting a custom term

For interactive signal configurations, you create custom terms to represent a pseudo-value for a drug 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 Drug 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 About custom terms.

Before you begin, consider the following:

• 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.

1.         Click the Signals tab.

2.         Click Drug Overviews.

3.         Click Manage Signaling Terms, and select Manage Custom Terms.

4.         To add a custom term:

A.        Click Create Custom Term.

B.        In the Name field, type a name for the custom term.

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

1. • \, /, <, :, >, |, ?, *, ”, &, and null

   • Control characters

   • Non-ASCII characters

C.        In the Item drop-down list, select the variable type for the term, for example, Drug.

D.        Click one of the following:

• • Create Using Query Wizard

  • Create From Existing Query

E.        Create a query to define the custom term. For more information see Creating a query from an existing query or Defining query conditions.

F.        In the Hierarchy Path field, click Select <hierarchy> term.

G.        Browse to the hierarchy path with which you want to associate the custom term.

H.        Click OK.

5.         To edit a custom term:

A.        In the table, locate the custom term to edit.

B.        Click the row menu () for the custom term, and then click Edit.

C.        Edit the fields as needed.

D.        Click OK.

6.         To delete a custom term:

A.        In the table, locate the custom term to delete.

B.        Click the row menu () for the custom term, and then click Delete.

A confirmation message appears.

C.        Click OK.