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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: Clinical Trials in Canada

Question Number 1:
In which division of the Canadian Drug Food and Drug Regulations would you find GCP requirements?
A
 C3
B
 C4
C
 C5
D
 C6

Question Number 2:
In the Canadian Food and Drug Regulations what does REB stand for?
A
 Regulatory Enquiry Bureau
B
 Research Ethics Board
C
 Requirements for Environmental Benefit
D
 Research Environment Bureau

Question Number 3:
Which of the following does NOT appear in the list of requirements for labelling of drug for a clinical trial in the Canadian Food and Drug Regulations?
A
 Expiry date
B
 That the drug should only be used by a qualified investigator
C
 The name and address of the sponsor
D
 The name and address of the investigator

Question Number 4:
According to the Canadian Food and Regulations for how long should clinical trial records be kept?
A
 2 years after the last marketing authorisation
B
 5 years
C
 15 years
D
 25 years

Question Number 5:
In Canada what is the timeline for the Minister to review an application to import or sell a drug for the purposes of a clinical trial?
A
 30 days
B
 35 days
C
 60 days
D
 90 days

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