Scheduled Signal Calculations & Alerts

The signal detection process involves running Signal Calculations on 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

Consider the following 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.
• To store Signal Calculations of different data sources in a single Statistical Data record, your Admin must enable multi-source signal data consolidation. 
• To use default parameter values (for example, MedDRA Query ID and/or Subgroups) for Signal Calculation runs, your Admin must configure Calculation Criteria on Signal Product Profiles.

How Vault Runs Scheduled Signal Detection

Your Admin sets the frequency and day on which automated signal detection runs. The following process outlines how Vault runs scheduled signal detection:

1. Vault runs Signal Calculations on PV data and creates Statistical Data and CSV attachments to store the results, depending on the Output Type on the calculations.
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 that meets the following criteria:
   • Is associated with a Signal Product Profile
   • Is associated with a Product Family or Aggregate Reporting Group
   • Is in the Queued state type
   • Has an End Date earlier than the day the Signal Monthly Calculate and Create Data job is scheduled to run.
     Your Admin may schedule Signal Reporting Periods for routine creation.
2. Vault runs Signal Calculations according to the following logic: 
   • If the associated Signal Product Profile includes Calculation Criteria (for example, MedDRA Queries and/or Subgroups), Vault runs the associated Signal Calculations that include these parameters and returns results specific to these parameters. For example, if a Calculation Criteria with a MedDRA Query value of Arthritis and a Subgroup value of Age Group exists for the Signal Product Profile, Vault runs the Signal Calculations within the Signal Calculations Setting that use the MedDRA Query and Subgroup parameters to return Case counts for Arthritis, segmented by Age Group.
     Vault then sets the Signal Reporting Period to the System Processing state type.
   • Otherwise, if the associated Signal Product Profile does not have Calculation Criteria, Vault looks at the associated Signal Calculations and: 
     • Sets the Signal Reporting Period record to the System Processing state type.
     • Runs each calculation with criteria values set on the Signal Calculation records.
   • 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. When filtering on datasheets and events on datasheets, Vault determines the datasheet and event are active if they meet the following criteria:

• The active start date is before the Reporting Period end date.
• The active end date is after the Reporting Period end date.

If an error occurs during part of a Signal Calculation run, records that Vault successfully created or updated before the point of failure will still be accessible. Contact your Admin to resolve the errors.

Records Created from Scheduled Calculation Runs

After running Signal Calculations, for each Product and event combination, Vault creates (if none exists) or updates records in the following order:

• The Product-Event Combination (PEC) for the Product Family or Aggregate Reporting Group and primary MedDRA Term combination.
• The PEC Period for the Product Family or Aggregate Reporting Group and primary MedDRA Term combination.
• To store the Signal Calculation results: 
  • For all calculations with an Output Type of Statistical Data Record or blank, Vault creates a Statistical Data record if none exists for the PEC Period, detection date, Source, Signal Source Data, and, when configured, Subgroup and Subgroup value combination. Otherwise, Vault updates the existing record. Vault sets the Statistical Data record to the System Processing state type and the Detection Type field to Routine.
  • For each calculation with an Output Type of CSV Attachment, Vault creates a CSV file and attaches it to the Attachments section of the first Statistical Data record matching on: 
    • MedDRA Query
    • Reporting period 
    • Source 
    • Product Family or Aggregate Reporting Group
      Vault replaces this attachment when the calculation is re-run and there are CSV updates.
• A file summarizing all the Signal Calculations that ran and its configuration parameters. For Signal Calculations at the MedDRA Query level and with an Output Type of CSV Attachment, Vault attaches the file in the Attachments section of the same Statistical Data record as the results file. For Signal Calculations at the PT level or with an Output Type of Statistical Data Record, Vault attaches the file in the Attachments section of the associated Signal Reporting Period. If another Statistical Data record is created from the Signal Calculation Run and the Signal Calculation Run is run again, Vault attaches a new configuration summary file to the appropriate record after the initial Statistical Data creation.
• If selected on the Signal Calculation, a Signal Case Series for all Statistical Data records associated with the Signal Reporting Period and a Signal Case Series for each Case count field for each associated Statistical Data record. Vault can generate Signal Case Series at the Preferred Term (PT) or MedDRA Query level.

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.