Signal detection in Veeva Safety Signal allows you to detect Product-Event Combinations (PECs) using calculations and assess them for signal qualification using alerts.
Prerequisites
Consider the following prerequisites:
- To perform signal detection, your Admin must configure safety views.
- To define the scope of signal detection for a Product Family, your Admin must configure Signal Product Profiles.
- For EVDAS data, your Admin must enable EVDAS data import and prepare EVDAS data for signal detection.
- To automate the signal detection process, your Admin must enable and configure scheduled Signal Calculations and alerts.
Signal Detection Process
The signal detection process includes the following steps:
- Run Signal Calculations to obtain disproportionality scores to identify PECs.
- 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 PECs that require further investigation, you can create a Safety Investigation from the Statistical Data record.