423 / 879
Event driven tolerance limits
Occurence of an
unwanted
situation
Missed or late
report of a serious
adverse event
(SAE)
Recurrence of an
unwanted
situation
CAUTION,
BE AWARE
AND INFORM
TRIGGER A
MITIGATION
PLAN OR
STOP
|
|
423 / 879
Event driven tolerance limits
Occurence of an
unwanted
situation
Missed or late
report of a serious
adverse event
(SAE)
Recurrence of an
unwanted
situation
CAUTION,
BE AWARE
AND INFORM
TRIGGER A
MITIGATION
PLAN OR
STOP