signal
- Guideline or reference source
- ICHE2C(R2) Guideline
- Definition
- Information that arises from one or multiple sources (including observations and experiments), that suggests a new potentially causal association, or a new aspect of a known association, between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify further action to verify. For the purpose of Section 16.2 of the PBRER, signals relate to adverse effects.
- Narrower Term
- closed signal
- ongoing signal
- safety signal
- validated signal
- Related Term
- sign
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