Start with the Signal Review Products page

You access all the functions you can perform on an individual product from the Products page.

  1. In the left navigation pane, click the Signal Review icon (Signal Review icon) to display the Products page. You can also get to the Products page by clicking the back arrow (Back arrow) from the Product-Event Combinations page.
  2. Select how to group monitored products by selecting one of the five product properties defined for the configuration using the Products By drop-down list:
    • Category: Customer-definable product field value set when adding or editing a product to monitor. A user with Manage Signal Configuration permission defines the acceptable product field values. Examples include Drug, Vaccine, or Cosmetics, or separation by therapeutic use or chemical class.
    • Complexity: Customer-definable product field value set when adding or editing a product to monitor. A user with Manage Signal Configuration permission defines the acceptable product field values.

      Complexity can be used in alert type definitions. Complexity level, periodicity, and birthdate determine if the alert type rule will be part of the data refresh. The default values are High, Medium, and Low. For example, a high-complexity-level product would get scheduled more frequently for review than a product with a lower complexity level.

    • Organization: Customer-definable product field value set when adding or editing a product to monitor. A user with Manage Signal Configuration permission defines the acceptable product field values. Your products can, optionally, be assigned to a (sub-)organization in the enterprise. For example, companies might define organizations for branded versus generic drugs, or regional products in an organization located in a separate country.
    • Product Group: (Default) Customer-definable grouping set when the product was added or edited. Examples include therapeutic areas and cardiovascular products.
    • Reviewer: Person responsible for reviewing the product-event combinations.
  3. When you select a group, the Products By cards update. Select a card to filter the Products table.

    The Products table lists the products you are monitoring, filtered by your Products By card selection.

  4. To customize the columns in the Products table, click the Header Action menu (Header Action menu icon) and select Columns. You can select columns to include, reorder them, and sort the Products table using up to three different columns.
  5. To download the Products table, click the Header Action menu (Header Action menu icon) and select Download.
  6. Perform additional actions on this product by choosing an action from the Row Action menu (Row Action menu icon):
    • View Product-Event Combinations: Select this link from the Row Action menu, click a product name, or click a total alert count to investigate product-event combinations for the product.
    • Enter Note: Enter or edit a note for a product to indicate:
      • Issues that have been identified and investigated for the product.
      • Signals that require further evaluation.
    • View Notes: View notes that have been entered about the product.
    • View Event Comments: View comments entered about product-event combinations.
    • View Sector Map for All: View a visual representation for a particular product across all System Organ classes (SOCs).
    • Manage Targeted Medical Events: Maintain a list of adverse events your organization wants to closely monitor for a particular product. You must have the View Signal Management and the Manage Signaling Terms permissions. This applies to Interactive Signal Configurations only.
    • Manage Listed Events: Maintain a list of adverse events listed on the product label. You must have the View Signal Management and the Manage Signaling Terms permissions to manage listed events. This applies to Interactive Signal Configurations only.
    • Edit: Edit monitored product properties. You must have the View Signal Management and the Manage Signaling Terms permissions to perform this task.
    • Rename: You can rename monitored products if you have the View Signal Management and the Manage Signaling Terms user permissions. This applies to Interactive Signal Configurations only.
    • Delete: When you delete a product, Oracle Empirica Signal removes it from the Products and Product-Event Combinations tables. Deletion will not succeed if there are notes for the product or comments about a product-event combination that include the product. You must have the Manage Signaling Terms user permission to delete a product.

    The right graphic details panel updates to match your card or product selection.

  7. To see details about a product, click a non-linked value in the Products table row. If you click a link, such as the product name or a total count, the Product-Event Combinations page displays.