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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: Seasonal Competition Quiz

Question Number 1:
A generic medicinal product is defined as one which has:
A
 The same qualitative and quantitative composition in active substances as the reference product
B
 The same pharmaceutical form as the reference medicinal product
C
 Bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies
D
 All of the above

Question Number 2:
What are the IEC quorum requirements according to the ICH GCP?
A
 Quorum should be as stipulated by the local regulations.
B
 Quorum should be as stipulated by the SOPs of the EC.
C
 Five members constitute the quorum
D
 Depending on the protocol, any of the above.

Question Number 3:
What of the four conditions below is Santa Claus most likely to be suffering from?
A
 Refsum’s syndrome
B
 Rosacea
C
 Romano-Ward syndrome
D
 Rubeosis iridis

Question Number 4:
Who has the PRIMARY responsibility for protecting subjects’ rights, safety, and welfare during a clinical trial?
A
 Sponsor
B
 Investigator
C
 IRB/IEC
D
 ICH

Question Number 5:
Which phase of clinical trials is conducted after applying for an NDA but before NDA is granted?
A
 Phase IV
B
 Phase IIIb
C
 Phase IIIa
D
 Phase 0

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