Signal management in one platform
A signal is information suggesting a new potentially causal association, or a new aspect of a known association, between a medicine and an event, which needs further investigation. GVP Module IX describes the process: detection, validation, analysis and prioritisation, assessment, and recommendation for action, with each step documented and tracked. Edriza runs that process on the same case data used for ICSRs and aggregate reports, and each signal record lists the cases behind it.
Detection
Signal detection in Edriza looks at your valid cases, coded in MedDRA (preferred terms), for each product and reporting interval. A detection run is started by a person. It applies these rules:
- an unlisted preferred term in two or more valid cases of the product in the interval;
- a fatal or life-threatening unlisted event, where one case is enough;
- a serious preferred term seen for the first time for the product;
- a listed preferred term whose count in the interval is at least twice the mean of the previous four intervals and at least three, when Edriza holds the earlier cases;
- disproportionality per product and preferred term, when your company has more than one product: the proportional reporting ratio (PRR) with its 95% interval, the reporting odds ratio (ROR) with its lower 95% bound, and the information component (IC) with IC025.
Each candidate opens a signal record with the figures and the cases behind it. Edriza does not validate, refute or close a signal by itself; those are decisions for your experts.
Validation, assessment and action
The signal record follows the GVP Module IX stages. Your experts validate or reject the signal, prioritise it, assess it with the case series and the literature, and record the recommendation and any action, such as an update of the reference safety information or a communication to the authority. Where your SOP requires a second person for a decision, for example to refute or close a signal, the second confirmation is requested and recorded. Clocks for each stage are shown, with reminders before a deadline.
Committee and communication
Signals that need a safety committee can be prepared for it from the record: the case series, the figures, the assessment and the proposed action. Decisions of the committee and communications to authorities or partners are kept with the signal, so the history of each signal is complete in one place.
Linked to aggregate reports
The signals opened, closed or evaluated during a reporting interval feed the signal sections of your PSUR, PBRER, PADER or DSUR. Because both come from one platform, the report and the signal tracker agree.
Audit trail
Every detection run, every opened or refreshed signal and every decision is recorded with who or what acted, when and why. An inspector can see when a signal was first detected, how long each stage took, and on what evidence it was closed.
Part of the end-to-end flow
Signal detection depends on good case data. Edriza processes cases from literature, local journals, the mail box, intake ICSRs and uploaded documents through one flow (see ICSR case processing and PV automation with AI), so the signals are detected on complete, consistently coded data.