Criteria fixed before the data arrives
Thresholds and methodology are agreed in advance, so signal evaluation isn't shaped by whatever the first few cases happen to look like.
What's included
What goes into the plan
- Data sources for signal review defined, including case data, literature, and other applicable safety databases
- Statistical and clinical thresholds agreed for what constitutes a signal worth evaluating
- Review frequency set so signal detection runs on a fixed cadence rather than an ad hoc basis
- An evaluation and escalation pathway defined for confirmed signals, tied to the Safety Management Plan
- Documentation standards set so every review cycle produces a traceable record
- The plan agreed with the sponsor before ongoing signal detection begins
The reference for every review cycle
This plan is what Ongoing Signal Detection and Evaluation runs against once the study is live.
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