The tabs that appear in the navigation bar depend on your account permissions and your Vault’s custom configuration.
For information on navigation items in all Safety Suite Vaults, see Navigate Vault Safety Suite.
Reporting Periods
You can track the reporting period for a particular Product Family. Signal detection that is carried out on a regular basis depends on the Product Family’s set reporting period.
Use the Reporting Periods tab to create signal product reporting periods.
Product-Events
You can view all detected Product-Event Combinations (PECs) in the Product-Events tab. From the Product-Event Combination record, you can see all the PEC Periods associated with this record. A PEC Period is a reporting period associated with a particular PEC.
Statistical Data
Statistical Data records include information about signals detected from PV data, such as Case counts and listedness. You can manage these records in the Statistical Data tab.
Safety Investigations
Through Safety Investigation workflows, you can track safety issues with medicinal products. Use Safety Investigation records to validate and evaluate signals.
Run Calculations
You can generate ad-hoc signal reports using the Signal Calculation Run records. These records allow you to run predefined calculations to detect signals within the Safety Database and preview the results. Access these records in the Run Calculations tab.