Causality assessment
In Safety & pharmacovigilance
Causality assessment is the judgment of whether the study treatment could have caused an adverse event. Investigators typically use categories such as related, possibly related, or not related, and consider timing, plausibility, other explanations, and what happened when treatment stopped. In many regions, if either the investigator or the sponsor thinks a relationship is reasonably possible, the case is handled as related.
Example
A rash appears two days after the first dose, improves when dosing stops, and returns when it restarts. The timing and the dechallenge\u2013rechallenge pattern point towards a related assessment.
Related terms
Career paths that use this
Turn the vocabulary into a career
The free CRLN Career Finder maps your background to a clinical-research role and builds a step-by-step roadmap. No cost, no card.
Get your free roadmap →Educational reference only. Where regional rules differ, follow the regulation and the written procedures that apply where you work.