1. PMDA JADER Signal Management Release Notes
  2. View data and scores in Signal Management
  3. Standard alert types automatically installed

Standard alert types automatically installed

The standard alert types are a predefined set of columns that you can apply to the Product-Event Combinations table.

They can help you identify and prioritize potential safety issues with pharmaceutical products.

For each configured alert, there is one alert type. Each alert type has a Label, Column Name, Description, and alert type rules based on either the product’s Review Period or Complexity level/Periodicity. The condition for each standard alert type rule matches the Where Clause in its corresponding user-accessible view.

The view for each alert type rule is a hidden view with columns and sort the same as its corresponding user-accessible view and Where Clause of the form <alert type name>_ALERT is not null.

Each installed alert type has four alert rules based on the review periods. The Condition and Selected columns are dependent on the review period. For example, there are the following Fatal alert conditions:
  • Condition for Fatal alert 1-quarter: FATALNEW_N_PRIOR1 > 0
  • Condition for Fatal alert 2-quarter: FATALNEW_N_PRIOR2 > 0
  • Condition for Fatal alert 3-quarter: FATALNEW_N_PRIOR3 > 0
  • Condition for Fatal alert 4-quarter: FATALNEW_N_PRIOR4 > 0

By default, the standard alert types are informational, active, and scheduled by Review Period. The JADER Signal Management-specific automatic alert types include the following:

  • SDR
  • Fatal
  • DME
  • TME
  • Pediatric
  • Elderly
  • New
  • Female
  • Male
  • Interaction

Parent topic: View data and scores in Signal Management