Scheduled Signal Calculations & Alerts

Learn how Vault automates signal detection processes such as Signal Calculations and signal alerts.

About Scheduled Signal Calculations & Alerts

The signal detection process involves running Signal Calculations on Vault Safety pharmacovigilance (PV) data, creating relevant records, and running the Signal Alert Rule Engine to flag Product-Event Combinations (PECs) as potential signals. Vault can automate these processes by scheduling signal detection based on your Admin’s configuration.

Prerequisites

To automate the signal detection process of running calculations and the signal alert rule engine, your Admin must enable and configure scheduled Signal Calculations and alerts.

How Vault Runs Scheduled Signal Detection

The following process outlines how Vault runs scheduled signal detection:

  1. Vault runs Signal Calculations on PV data and creates Statistical Data records to store this output.
  2. Vault runs the Signal Alert Rule Engine to flag Statistical Data records as potential signals.

Scheduled Signal Calculations

Vault runs Signal Calculations as follows:

  1. Vault looks for every Signal Reporting Period in the Queued state type that is associated with a Signal Product Profile.
  2. If the associated Signal Product Profile includes Signal Calculations:
    1. Vault sets the Signal Reporting Period record to the System Processing state type.
    2. Vault runs each calculation in the Signal Calculation record.
    3. Vault creates the following records:
      • A Product-Event Combination (PEC) record if none exists for the Product Family and primary MedDRA Term combination.
      • A PEC Period record if none exists for the Product Family and primary MedDRA Term combination.
      • A Statistical Data record if none exists for the PEC Period and Detection Date combination. Vault sets the Statistical Data record to the System Processing state type.

If your Admin did not configure Signal Calculations for the Signal Product Profile, Vault sets the Signal Reporting Period to the Ready state type. For this Signal Reporting Period, Vault stops the scheduled job.

In the scenario where you update a Signal Reporting Period while Vault is running the scheduled job, Vault considers the start and end dates before the update.

Scheduled Signal Alert Rule Engine

After running Signal Calculations and creating the relevant records, Vault runs the Signal Alert Rule Engine as follows:

  1. If the associated Signal Product Profile includes Signal Alert Rule Sets, Vault runs the Signal Alert Rule Engine to evaluate each Signal Alert Rule in the set on every Statistical Data record in the System Processing or Initial state type, associated with the evaluated Signal Reporting Period.
  2. Once the rules are evaluated on the applicable Statistical Data records, Vault sets the Statistical Data records to either the Ready or Complete state type, depending on if the record meets Signal Alert Rule criteria.
  3. Once all applicable Statistical Data records have been evaluated, Vault sets the Reporting Period state type to Ready.

If your Admin did not configure Alert Rule Sets for the Signal Product Profile:

  • Vault sets the Signal Reporting Period associated with the Signal Product Profile to the Ready state type.
  • Vault sets the Statistical Data record to the Ready state type.

In the scenario where your Admin updates Signal Alert Rule Sets and Signal Alert Rules while Vault is running the scheduled job, the Signal Alert Rule Engine considers the rule sets and rules before the update.

Scheduled Signal Detection Errors

When Vault encounters an error during the scheduled run, Vault sends a notification to the job owner (by default, this is the System Administrator) for each Signal Reporting Period that resulted in an error and sets the relevant Signal Reporting Periods to the Error state. The notification includes error details such as the Signal Calculation, Statistical Data record creation, or Signal Alert Rules that failed.

For any Signal Reporting Period where an error has occurred, Vault stops any further processing.