What's included

What goes into ongoing signal detection

• Systematic, ongoing review of processed case data against the methodology and thresholds agreed in the Signal Detection Plan
• Data mining and literature surveillance to catch emerging trends rather than relying on a once-a-cycle review
• A defined evaluation and escalation pathway, documented for every signal considered — not just those confirmed
• Confirmed signals routed into aggregate safety reporting and safety monitoring committees on a set cadence
• An audit-traceable signal evaluation record defensible under sponsor or agency review