Manage monitored drugs and signaling terms

You can use the interactive Signal Management feature in Oracle Empirica Signal to define the list of monitored products and signaling terms from the application user interface.

You can manage the products to monitor and the following signaling terms:

• Designated medical events
• Custom terms
• Targeted medical events
• Listed events for a monitored product

For more information about monitoring products and maintaining signaling terms, see Add, edit, or change the name of a monitored product and Manage events and custom terms in the User Guide and Online Help.

To modify the list of monitored products and signaling terms:

• The interactive signal configuration must be selected for your user.
• You must have the Manage Signaling Terms user permission.

1. In the Oracle Empirica Signal application, in the navigation pane on the left, click the Signal Review icon ().

   The Products page appears.

2. If the interactive signal configuration is not displayed in the Signal Configuration drop-down list, select it.
3. From the Manage Reference Data menu () in the upper right corner, select Add Product or Manage Custom Terms.
4. To add or edit products, fill in the fields according to the table in Add, edit, or change the name of a monitored product in the User Guide and Online Help. To manage signaling terms, see Add, edit, or delete a custom term in the User Guide and Online Help.

To manage events:

1. In the left navigation pane, click the Signal Review icon ().
2. If necessary, filter the Products table by selecting a product grouping from the Products By drop-down list, then selecting a card.
3. Click the product's Row Action menu () and select the appropriate command.

   

4. To manage designated medical events, click the Manage Reference Data menu () in the upper right corner, and select Manage Designated Medical Events.
5. Follow the steps in Manage events and custom terms in the User Guide and Online Help.