Signal review, a feature of the Oracle Empirica Signal and Topics application, is used to view disproportionality analysis statistics for successive updates of safety data, allowing you to monitor alerts and evaluate changes in safety signals over time.

The Products and Product-Event Combinations pages provide graphical and tabular alert information at all levels. Reviewers can easily assess the review completeness of alerts for all products or specific product groupings.

• Signal Review basics
  Signal Review, a feature in the Oracle Empirica Signal and Topics application, is used to view disproportionality analysis statistics for successive updates of safety data, allowing monitoring of alerts and evaluating of changes in safety signals over time.
• Step 1: Select a signal configuration
  Selecting the configuration you want to apply is the first step in performing a signal review.
• Step 2: Select a product, group of products, or multiple products to investigate
  Selecting the products to investigate is the second step in performing a signal review.
• Step 3: Review product-event combinations for a product or multiple products
  The Product-Event Combinations panel is a set of tables that represent views of the product-event combinations assembled from the current Refresh runs, as well as rows from previous refreshes which have either unreviewed alerts or comments.
• Step 4: Submit the review
  The Submit Review page groups together all the functionality related to completing a review and documenting the disposition of a product-event combination and the alerts raised for that product-event combination.