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 view parameters. If the Calculation field is blank, running the Signal Calculation Run executes all Signal Calculations in the Active state associated with the Signal Calculations Setting.
  3. Expand the Filters section and each filter group to provide filter values as needed and to apply additional filters.
    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.

Results

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 action fails due to a SQL error, Vault creates an error log in Business Admin > Objects > Workbench Logs. By default, Vault sorts these logs by the day and time the error was encountered, starting with the most recent. In the Workbench Log Data field, select the attachment to download the error log to review and resolve the issues.

If an advanced calculation fails to generate a score for a PEC, Vault completes the action and includes descriptive advanced calculation error messaging for:

  • Ad-hoc calculation runs in the Preview section 
  • Ad-hoc calculation runs in the downloaded CSV file
  • The Advanced Calculation Errors field on Statistical Data records created from scheduled or ad-hoc calculation runs

Calculation failures can occur in the following scenarios:

  • The Empirical Bayes Geometric Mean (EBGM) calculation cannot converge (settle on a stable and reliable score). 
  • The EBGM calculation does not have enough or valid data. For example, when there are no results for the product of interest or the calculation includes division by zero.
  • The Information Component (IC) results in a negative or positive infinity.

Download Signal Calculation Results as CSV

To download Signal Calculation results to a CSV 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.

Results

If a Signal Calculation was specified on the Signal Calculation Run, Vault creates a single CSV file. 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 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