Learn about Signal Individual Case Review (ICR) records and how to review them.
About Signal Individual Case Reviews
Individual Case Safety Reports (ICSRs) are regularly reviewed as part of qualitative signal detection and analysis. The review is performed separately from and does not impact Case processing. To facilitate this review, Vault uses Individual Case Routing Criteria to determine when a Case qualifies for review as part of signal analysis to create Signal ICRs.
Prerequisites
Before you can use this feature, your Admin must configure the following:
Example Signal Individual Case Review Creation Scenarios
Your Admin must configure the Individual Case Routing Criteria that a Case must meet to qualify for signal review. The following table describes example scenarios for the Individual Case Routing Criteria outcomes:
| Scenario | Case Action | Routing Tag |
|---|---|---|
| A Case meets the routing criteria for Medical Review (for causality assessment as part of Case processing) and for review as part of signal detection. Vault tags the Case for Medical Review and Individual Case Review and creates an ICR. |
Create Signal Individual Case Review, Tag Case | Medical Review, Signal Review Required |
| A Case meets the routing criteria for review as part of signal detection. The Case does not require Medical Review for causality assessment. Vault tags the Case for Individual Case Review and creates an ICR. |
Create Signal Individual Case Review, Tag Case | Signal Review Required |
Vault creates a Signal ICR for each Case Product on the Case Assessment that meets the Case routing criteria and qualifies for signal review. When a Signal ICR is created or when the Case Product on the record is updated, Vault updates the Product Family on the Signal ICR using the Product Family on the Product record.
Review Signal Individual Case Reviews
For each unique Case Product on the Case Assessment that meets the routing criteria and qualifies for signal review, Vault creates a Signal ICR. To review these records:
- Navigate to the Individual Case Reviews tab.
- Select a Signal Individual Case Review.
- Review the record and select a disposition according to your business processes.
- If you created a Safety Investigation as part of the previous step, navigate to the respective record in the Safety Investigations tab and populate the fields as needed.