1. FDA AERS Signal Management Installation and Upgrade Instructions
  2. Install and configure an interactive AERS signal configuration
  3. Manage monitored drugs and signaling terms

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

To modify the list of monitored products and signaling terms:

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

    The Products page appears.

  2. If the interactive Oracle Argus Mart signal configuration is not displayed in the Signal Configuration drop-down list, select it.
  3. From the Manage Reference Data menu (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 and term of a monitored product, or to manage signaling terms, see Add, edit, or delete a custom term in theUser Guide and Online Help.
To manage events:
  1. In the left navigation pane, click the Signal Review icon (Signal Review icon).
  2. To manage listed events or targeted medical events, click the product's Row Action menu (Row Action menu icon) and select the appropriate command.

    Manage listed or targeted events from the Row Action menu

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

Parent topic: Install and configure an interactive AERS signal configuration