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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The subject is withdrawn from the study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
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