Perform a periodic review

Signal management configurations have a granularity, such as monthly or quarterly. The review period is set up during installation based on this granularity. For example:

  • FDA AERs review periods are 3, 6, 9, and 12 months.
  • Argus review periods are typically 1, 3, 6, and 12 months.
  1. In the left navigation pane, click the Signal Review icon (Signal Review icon).
  2. (Optional) From the Products By drop-down list, select a product grouping, then select a card to filter the Products table.
  3. Select the product, click the Row Action menu (Row Action menu icon) icon, and select View Product-Event Combinations, or click the product name or total count.

    The Product-Event Combinations table shows the events, status, alerts, review periods, and comments related to the product-event combinations.

  4. Select a product with the Alerts need to be reviewed icon icon in the Status column. The icon denotes that the product-event combination has alerts that haven't been reviewed. The Alerts have been reviewed icon icon denotes that alerts have been reviewed. The Topics are associated with the product-event combination icon icon denotes that topics are associated with the product-event combination.
  5. To view cases new since a specific review period, click the bold total in an N or Nsince column to open a menu that provides access to case review functions and reports.
  6. Use the Row Action menu (Row Action menu icon) to access additional functions.
  7. When your review is complete, from the Row Action menu (Row Action menu icon) select Submit Review.
  8. Submit the review.

Frequency of evaluations

The frequency for evaluations is specified when the administrator selects the menu item to add the product for monitoring; for example, every 3 months, 6 months, or 1 year. That choice is reflected on the Product-Event Combinations table.

The All column shows alerts since the previous quarter. Likewise, if a product has a nine-month periodicity, the All column shows the alerts for the nine months prior.

Note:

To specify review periods, the administrator must enable the Review Period column and Review Period filter on the Manage Signal Views page. To disable review periods, the administrator selects the Disable review period option on the Edit Signal Configuration page.