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 supported data source. You can run Signal Calculations for the following data sources:
- Safety (pharmacovigilance)
- FDA Adverse Event Reporting System (FAERS)
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.
Note: If scheduled signal detection is in the process of running Signal Calculations, you cannot manually run the Signal Calculations.
Prerequisites
Consider the following prerequisites:
- To run Signal Calculations, your Admin must Configure Signal Calculation Objects.
- For the FAERS data source, your Admin must configure calculations and Statistical Data creation.
- To store Signal Calculations in CSV format, your Admin must configure Signal Calculations for MedDRA Queries.
Run & Preview Signal Calculations
To run calculations and preview calculation results:
- Navigate to the Run Calculations tab.
- 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 associated with the Signal Calculations Setting. - 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. - From the All Actions menu, select Calculate.
- 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.
Note: When previewing the Signal Calculation results, fields that do not exist on the Statistical Data object do not appear in the Preview section. This does not affect the calculation data or Statistical Data creation. This limitation will be addressed in a future release.
Result
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.
Download Signal Calculation Results as CSV
To download Signal Calculation results to a CSV file:
- Navigate to the Run Calculations tab.
- Select a Signal Calculation Run record.
- 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 calculations associated with the calculations setting, Vault creates:
- A CSV file for each Signal Calculation with an Output Type of CSV Attachment. If multiple Signal Calculations return data for the same Product Family-MedDRA query combination, Vault merges this data into one CSV file
- A single CSV file containing all Signal Calculations with an Output Type of Statistical Data Record or blank