Run Signal Calculations

You can run Signal Calculations to obtain Case counts and scores that help you determine whether a specific adverse event occurs disproportionately for a specific product. On Signal Calculation Runs, you can specify the type of calculation you will run on all data for a single or all associated data sources.

Based on your Admin’s configured Signal Calculations, you can run calculations to detect Product-Event Combinations (PECs) on all or a subset of data for specified reporting periods. You can also run ad hoc calculations outside of a product’s reporting period. Optionally, for a more specific output, you can add safety view filters to the calculation run record. After running a Signal Calculation, you can preview the data in the Preview section or by saving the results in a CSV file.

For a broader look at the signal detection process, see the Signal Detection Overview.

Subgroups

Subgroups allow you to analyze Safety data for potential signals in specific populations and identify whether a safety concern is isolated to this specific population. Running calculations with subgroups segments Product Families to provide a nuanced look. For example, if identifying potential signals within a Product Family based on Sex, Vault returns results for the Female and Male populations.

For Signal Calculations configured with subgroups, Vault returns data segmented into the following categories based on your Admin’s configuration: 

  • Age Group
  • Indication
  • Receipt Year
  • Region
  • Route of Admin
  • Sex

Prerequisites

Consider the following prerequisites:

Run & Preview Signal Calculations

To run calculations and preview calculation results:

  1. Navigate to the Run Calculations tab.
  2. Select a Signal Calculation Run record.
    The Calculations Setting and Calculation fields provide more detail about the calculation, including any criteria filters. See how Vault runs Signal Calculations based on the Calculation field.
  3. If available, expand the Filters section and each filter group to provide filter values as needed:
    • Criteria: Special parameters that change the output based on your Admin’s configuration.
    • Required: The filters inherited from the safety view that are required or not editable. 
    • Optional: The filters inherited from the safety view that are editable and not required. 
    • Additional: You can add these filters directly on the Signal Calculation Run. For certain text, object, and picklist field filters, you can paste rows of data from an external tool.
      If the Signal Calculation Run is set to execute all calculations associated with the Signal Calculations Setting (the Calculation field is blank), Vault does not display available filters and populates them based on the selected Reporting Period.
  4. From the All Actions menu, select Calculate. Calculation results expire after seven days and you must select this action again before previewing, storing, or downloading results.
  5. Expand the Preview section and then select Preview.
    If the run is set to execute all calculations associated with the Signal Calculations Setting, Vault inactivates the Preview button.

Vault displays a preview of the calculation results to a maximum of 100 Cases. If you leave the page, the Preview section clears. To store the results of a Signal Calculation, create Statistical Data records. If the Calculate action results in an error, contact your Admin.

How Vault Runs Signal Calculations

Vault runs Signal Calculations using the following logic:

  • If the Calculation field on the Signal Calculation Run is blank, Vault looks at the associated Signal Reporting Period’s Signal Product Profile for any Calculation Criteria. This criteria defines default values for parameters, such as MedDRA Queries and/or Subgroups, when running Signal Calculations.
    • If the Signal Product Profile includes Calculation Criteria, the Filters section does not appear on the Signal Calculation Run and 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.
    • Otherwise, if the Signal Product Profile does not have Calculation Criteria, Vault executes all Signal Calculations in the Active state associated with the Signal Calculations Setting. 
  • If the Calculation field on the Signal Calculation Run is populated, Vault runs this Signal Calculation based on its configuration and filters.

Download Signal Calculation Data

You can download Signal Calculation result files and a configuration summary file:  

  1. Navigate to the Run Calculations tab.
  2. Select a Signal Calculation Run record.
  3. From the All Actions menu, select Download all as CSV.

Signal Calculation Result Files

If a Signal Calculation was specified on the Signal Calculation Run, Vault creates a single CSV file with Signal Calculation results. In the scenario where the Calculation field on the Signal Calculation Run was left blank and the run executed all active calculations associated with the calculations setting, Vault creates a ZIP file with multiple Signal Calculation result CSVs using the following logic:

  • If the Results Output on the Signal Calculations Setting is Multiple Records:
    • A CSV file for each Signal Calculation for each data source with an Output Type of CSV Attachment. For calculations of an external data source, Vault names the file accordingly, for example, faers_calculation_result_SCALC-00001. If multiple Signal Calculations return data for the same Product Family-MedDRA query or Aggregate Reporting Group-MedDRA query combination, Vault merges this data into one CSV file.
    • A CSV file containing all Signal Calculations with an Output Type of Statistical Data Record or blank. For calculations of different sources, Vault creates separate CSV files for each.
  • If the Results Output on the Signal Calculations Setting is Single Record:
    • A CSV file for each Signal Calculation with an Output Type of CSV Attachment. Vault includes all calculation scores for a PEC in a single CSV file, regardless of the data source. For example, if calculations of the Safety and FAERS data source detect the same PEC, Vault includes these calculations in the same row in the CSV. If multiple Signal Calculations return data for the same Product Family-MedDRA query or Aggregate Reporting Group-MedDRA query combination, Vault merges this data into one CSV file. 
    • A CSV file containing all Signal Calculations with an Output Type of Statistical Data Record or blank, regardless of the data source

Configuration Summary Files

In addition to the CSV result files in the ZIP, Vault includes a configuration summary file for all Signal Calculations that ran. The configuration summary file contains four sheets: 

  • General: Includes system and job information, such as the calculation run date and user, as well as data information, such as the Product Family or Aggregate Reporting Group, the Signal Product Profile, and Data Source. 
  • Calculations: Includes information such as the Signal Calculations Setting, Signal Calculation Run, the configuration parameters for each Signal Calculation (safety view, query type, and calculation type), and the active MedDRA version at the time of the data sync from Safety.
  • Filters: Includes information such as the Filter View name, the filter fields, operators, and values, as well as advanced logic for each Signal Calculation.
  • Alerts: Includes information such as the Signal Alert Rule Set and the Signal Alert Rules that ran on the data.

The timezone, date, and language localization depends on either the user who ran the Signal Calculation Run, or the Vault’s base settings for scheduled runs. Running the Signal Calculation Run again generates an updated configuration summary file.