Learn how to configure signal calculation objects for signal detection and reporting.

About Signal Calculation Objects

Signal calculation objects run simple and advanced calculations on the Safety database to return a list of Product-Event Combinations (PECs). Users can use these objects to manually run calculations against the PV data to generate ad-hoc reports.

Signal calculation objects include:

  • Signal Calculations Setting: This object groups Signal Calculations together for a particular Product Type, for example, Drugs.
  • Signal Calculations: This object allows you to specify whether a simple (SQL) or advanced (for example, EBGM) calculation will be used in the run. This object also references a safety view and its configuration (for example, SQL and filters) for the run.
  • Signal Calculation Runs: This object references a Signal Calculations Setting and Signal Calculation to accomplish the following:
    • Admins can troubleshoot and test the calculation setup.
    • Users can manually run ad-hoc signal calculations.

For more information on calculations, see Signal Detection Calculations.

Prerequisite

To use advanced EBGM calculations in signal calculation runs, you must first enable advanced (EBGM) calculation for safety data.

Create Signal Calculations Settings & Signal Calculations

Follow the steps below to create Signal Calculation Settings and Signal Calculation records:

  1. Navigate to Business Admin > Objects > Signal Calculations Settings.
  2. Select Create.
  3. Complete the following information:
    • Name: Enter a name for the Signal Calculations Setting. For example, “Drugs from Safety Database”.
    • Description: (Optional) Enter a description for the Signal Calculations Setting.
  4. Select Save.
  5. To add Signal Calculation records to the Signal Calculations Setting, expand the Calculations setting and select Create.

    A Create Signal Calculation window appears.

  6. Complete the following information:
    • Query Type: Select an option from the drop-down. Select SQL or Advanced from the drop-down.
      The SQL option references the SQL in the associated safety view, whereas the Advanced option uses more complex calculations (for example, EBGM).
      • Calculation: If you selected the Advanced query type, this field appears and is required. Select an advanced calculation option from the drop-down.
    • Signal View: Select a safety view from the drop-down or select the Advanced Search (saf-binoculars-icon) icon to use filters and refine your search.
  7. Select Save.
  8. Create additional records as needed.

If this Signal Calculation uses the Advanced query type option, you must specify the calculation mapping.

Signal Calculation Mapping

This section applies to Signal Calculation records with the Advanced query type only. Vault allows you to map advanced calculation values to the corresponding field on the Statistical Data record.

Simple calculation (SQL) field mapping is already defined on the safety view. For advanced calculations, you can configure custom field mapping that can then be used to stratify data for an EBGM score.

To configure signal calculation mapping:

  1. In the relevant Signal Calculation record with EBGM as the selected calculation, expand the Calculation Mapping section.
  2. Select Create.
    A Create Signal Calculation Mapping window appears.
  3. Complete the following information:
    • From the Calculation Output Value drop-down, select an option.
    • Enter the Target Field Name (ending in __v).
  4. Optional: Add additional Signal Calculation Mappings as needed.
  5. Select Save.

Results

When you run this calculation against PV data, Vault returns the above scores and displays them in the target field on the Statistical Data record.

Create Signal Calculation Runs

Follow the steps below to create Signal Calculation Runs:

  1. Navigate to Business Admin > Objects > Signal Calculation Runs.
  2. Select Create.
  3. Complete the following information:
    • Name: Enter a name for the Signal Calculation Run.
    • Calculations Setting: Select an option from the drop-down or select the Advanced Search icon to use filters and refine your search.
    • Calculation: Select an option from the drop-down or select the Advanced Search icon to use filters and refine your search. After selecting a calculation, the Filters section inherits the filters configured on the associated safety views. For more information about inheriting filters from the safety views, see Add Safety View Filters in Safety Signal.
    • Reporting Period: Select an option from the drop-down or select the Advanced Search icon to use filters and refine your search.
  4. In the Filters section, expand each filter group and define any filter parameters as needed. You can also add additional filters to this calculation run. See Add Safety View Filters in Safety Signal for instructions.
  5. Select Save.

Results

When a user runs this Signal Calculation Run, Vault considers the query type and all related filters when returning the results.

For more information about running signal calculations, see Signal Detection Using PV Data.