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Weekly GCP Challenge

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.


Challenge: Adverse events - case studies

Question Number 1:
A subject in a trial develops a viral infection, which of the following would constitute a Serious Adverse Event according to ICH GCP?
A
 The subject is withdrawn from the study
B
 The subject develops a post viral syndrome which means he has to reduce his working hours for 6 months.
C
 The subject develops a chest infection which is treated at home with antibiotics
D
 None of the above

Question Number 2:
A subject in a clinical trial has an unexpected heart attack which requires hospitalisation, and which the investigator feels is related to the study drug, but on unblinding the subject turns out to be on placebo. How should the sponsor report this?
A
 As an SAE unrelated to the Product
B
 As a SUSAR, but stating that the subject was taking placebo
C
 As an AE
D
 The sponsor must decide how to report it

Question Number 3:
A subject experiences a bereavement during a clinical trial, what circumstances would make it advisable to report this event?
A
 The subject withdraws from the study but doesn't wish to give a reason
B
 The subject experiences clinical depression following the bereavement
C
 It should be reported as an adverse event in any case
D
 It should never be reported

Question Number 4:
A subject becomes pregnant during a clinical trial, is this an adverse event according to ICH GCP?
A
 Yes, it's automatically an SAE
B
 Yes it's automatically an AE
C
 No, but pregnancy is often reported as a serious adverse event
D
 No, and it should only be reported if complications arise

Question Number 5:
A subject in a clinical trial goes for a botox injection (which is completely unrelated to the trial) and has a severe reaction to the botox. Is this an adverse event?
A
 Yes
B
 No
C
 It depends whether the investigator thinks it's related to the study drug.
D
 No, but it should be reported anyway.

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