The third way of adding a signal to Evidex Signal Management (ESM) is through automated Surveillance via the Surveillance - FAERS and Surveillance - ICSR tabs. Automated Surveillance assigns user-specific algorithms to products associated with an organization’s ESM configuration, and automatically surfaces the potential signals identified by that algorithm as Active Safety Relevant Observations (SROs).
This automated process allows a reviewer to triage the signals and make the decision to add them to the signal management process.
By clicking on the Surveillance tab, the Surveillance - ICSR and Surveillance - FAERS sub-tabs appear, and a user can view all of the potential signals here. Admin Users have the capability to edit their signal criteria for each drug by clicking the edit icon next to a drug name. The Surveillance sub-tabs allow Admin Users to set their organization’s custom signal criteria for a drug by clicking the edit icon in the Algorithm column. Any criteria entered in the modal pop-up will be applied to every adverse event for the given drug, and the page will re-load after clicking “Submit” at the bottom of the pop-up. Right from the SRO table, a reviewer can set the Status, Add the observation to Evidex Signal Management, or click on the Preferred Term to begin to review the potential signal by viewing the Drug/AE Analysis page in Evidex. Clicking on the Drug Name will bring users to the Drug Page - Overview tab in Evidex.
