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Answer the questions below and then click the button. The next page will mark your answers and show you how well you have done compared with the previous people who have taken the tests.

Test: ICH - Adverse Events

Question Number 1:
Of what is this the ICH Definition: A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function?
A
 Adverse Event
B
 Adverse Drug Reaction
C
 Serious Adverse Event
D
 SUSAR

Question Number 2:
According to ICH which of the following is most true regarding the terms "serious" and "severe" when reporting AEs?
A
 They are interchangeable
B
 The term "severe" should not be used when reporting AEs so as to avoid ambiguity
C
 Seriousness is based on outcome/action where severity refers to the intensity of an event
D
 Adverse events which are severe should always be classified as serious

Question Number 3:
According to ICH what is the definition of "life-threatening" in classifying adverse events?
A
 A condition which could cause death immediately or if it continued to progress.
B
 An event where the subject needed resuscitation.
C
 An event which caused the subject to believe they were going to die.
D
 An event in which the patient was at risk of death at the time of the event; but not one which could have caused death if it had become more severe.

Question Number 4:
According to ICH what is the minimum information required in transmission of an Adverse Event report?
A
 Patient, AE reporter, Event, Suspect Drug(s)
B
 Patient, Event, Suspect Drug(s), Outcome
C
 Event, Reporter, Suspect Drug(s), Causality Assessment
D
 Event, Reporter, Suspect Drug(s), Outcome

Question Number 5:
If all information for a complete report on a fatal SUSAR is not available within 7 days, what is the deadline for a follow up report?
A
 Another 7 days
B
 Another 8 days
C
 Another 15 days
D
 There is no specific deadline

 
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