SAEs: Causality

The assignment of causality should be made by the Investigator responsible for the care of the participant. The Chief Investigator (or Clinical Reviewer Delegate) will also be responsible for making an assessment of causality.

Relationship
Description
Unrelated There is no evidence of any causal relationship with the trial/study or intervention.
Unlikely There is little evidence to suggest there is a casual relationship (e.g. the event did not occur within a reasonable time after intervention), with the study/trial or intervention. There is another reasonable, explanation for the event (e.g. the participant’s clinical condition, other treatment).
Possible There is some evidence to suggest a causal relationship with the trial/study or intervention (e.g. because the event occurs within a reasonable time after intervention). However, the influence of other factors may have contributed to the event (e.g. the participant’s, clinical condition, other treatments).
Probable There is evidence to suggest a causal relationship and the influence of other factors is unlikely.
Definite There is clear evidence to suggest a causal relationship and other possible contributing factors can be ruled out.
Not assessable
There is insufficient or incomplete evidence to make a judgement of the causal relationship.