Signal detection in Veeva Safety Signal allows you to detect Product-Event Combinations using calculations and assess them for signal qualification using alerts. The information on this page applies to the following data sources:
- Safety (pharmacovigilance)
- FDA Adverse Event Reporting System (FAERS)
Prerequisite
To perform signal detection, your Admin must configure safety views.
Signal Detection Process
The signal detection process includes the following steps:
- Run Signal Calculations to obtain disproportionality scores to identify Product-Event Combinations.
- Create Statistical Data to store Signal Calculation results.
- Run signal alerts to determine whether disproportionality scores meet the threshold to qualify as potential signals.
- For confirmed Product-Event Combinations that require further investigation, you can create a Safety Investigation from the Statistical Data record.
About PV Signal Detection
Pharmacovigilance (PV) data is transferred daily from Safety to a Signal database. Signal can then perform signal detection for Product-Event Combinations (PECs) from Safety Cases. As part of the signal detection process, you can run Signal Calculations and alert rules on Safety data as well as create records detailing the results, or your Admin can configure a schedule to automate this process.