Signal calculation objects run simple and advanced calculations to return a list of Product-Event Combinations (PECs). Users can use these objects to manually run calculations against data sources to generate ad-hoc results.
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 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.
Prerequisites
Consider the following prerequisites:
- Configure your Vault to use the following advanced calculations in Signal Calculation Runs:
- To store Signal Calculations of different data sources in a single Statistical Data record, you must enable Multi-Source Signal Data Consolidation.
Create Signal Calculations Settings
To create Signal Calculations Settings records:
- Navigate to Business Admin > Objects > Signal Calculations Settings.
- Select Create.
- Complete the following information:
- Name: Enter a name for the Signal Calculations Setting. For example, “Drugs from Safety Database”.
- Description: Enter a description for the Signal Calculations Setting.
- Results Output: Select one of the following options from the drop-down:
- Single Record: Select this option to save all Signal Calculation Run results in a single Statistical Data record, regardless of the data source. If you select this option, consider the following requirements to ensure a successful calculation run:
- Signal Calculations must reference Signal Views at either the MedDRA query level or Preferred Term (PT) level, but not both.
- Signal Calculations must not be associated with Signal Views for subgroups.
- Multiple Records: Select this option to save Signal Calculation Run results with different data sources in separate Statistical Data records. If you leave the Results Output field blank, Vault defaults to this behavior.
- Single Record: Select this option to save all Signal Calculation Run results in a single Statistical Data record, regardless of the data source. If you select this option, consider the following requirements to ensure a successful calculation run:
- Select Save.
Create Signal Calculations
To add Signal Calculation records to the Signal Calculations Setting:
- Expand the Signal Calculations section and select Create.
- In the Create Signal Calculation dialog, complete the applicable fields.
- Select Save.
- View parameters configured on the associated safety view appear in the Filters section. Expand the section to provide parameter values as needed. For Signal Calculations associated with Signal Views for subgroups, you must select the subgroups from the Signal Subgroups Picklist for which Vault will segment the PEC results. If you want to add custom Subgroup picklist values, contact your Veeva Representative.
- Create additional records as needed.
If this Signal Calculation uses the Advanced query type option, you must specify the calculation mapping.
Signal Calculation Fields
| Field | Description |
|---|---|
| Query Type | 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. |
| Calculation | If you selected the Advanced query type, this field appears and is required. Select an advanced calculation option from the drop-down. |
| Prior Used | If you selected the IC calculation, this field appears and is required. This field affects the amount of shrinkage, meaning how much the calculation shrinks the estimated case counts for rare PECs to provide a more stable and reliable estimate. The following options are:
|
| Signal View | Select a Signal View from the drop-down or select the Advanced Search ( ) icon to use filters and refine your search. To return Safety data at the Product Family-MedDRA query level or Aggregate Reporting Group-MedDRA query level, select the appropriate MedDRA Query view; MedDRA query level views support Safety data only. Otherwise, Vault returns results at the Product Family-MedDRA event level or Aggregate Reporting Group-MedDRA event level. |
| Case Series View | If you selected the SQL query type, this field appears. Select a Signal Case Series view from the drop-down or select the Advanced Search icon to use filters and refine your search. To use a Signal View as a Case series, you must enable the Signal Case Series Enabled checkbox on the respective view. |
| Data Source | If the Signal View is for a non-Safety database, Vault populates the respective data source. For the Safety database, Vault leaves this field blank. A Signal Calculations Setting supports Signal Calculations of different data sources. |
| View Parameters | Vault populates view parameter information. |
| Output Type | From the picklist, select the type of output for storing the results of the Signal Calculation:
|
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 advanced calculation score.
To configure signal calculation mapping:
- In the relevant Signal Calculation record with an advanced calculation as the selected calculation, expand the Calculation Mapping section.
- Select Create.
A Create Signal Calculation Mapping dialog appears. - Complete the following information:
- From the Calculation Output Value drop-down, select an option.
- Enter the Target Field Name (ending in
__v).
- Optional: Add additional Signal Calculation Mappings as needed.
- 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:
- Navigate to Business Admin > Objects > Signal Calculation Runs.
- Select Create.
- 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. If you leave this field blank, when a user runs the Signal Calculation Run, Vault runs all Signal Calculations associated with the Signal Calculations Setting. Additionally, if this field is blank, you cannot add filters to the Signal Calculation Run.
- Reporting Period: Select an option from the drop-down or select the Advanced Search icon to use filters and refine your search.
- In the Filters section, expand each filter group and enter values for all required filters. Define optional filter parameters as needed. You can also add additional filters to this calculation run. See Add Safety View Filters in Safety Signal for instructions.
- Select Save.
Note: When you add filters to a Signal Calculation Run, you must apply the same filters to all Signal Calculations in the Signal Calculations Setting to ensure data consistency.
Results
When a user runs this Signal Calculation Run, Vault considers the query type and all related filters when returning the results.