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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 Children

Question Number 1:
What is the term used to describe the process of providing information about a clinical trial to a child and asking if they would like to take part?
A
 Consent
B
 Proxy consent
C
 Assent
D
 Assertion

Question Number 2:
At what age can a child give consent to take part in a clinical trial?
A
 13
B
 16
C
 18
D
 It depends on local legislation

Question Number 3:
In the EU what additional requirement is there for an Ethics Committee to review a clinical trial using children?
A
 It must have access to paediatric expertise
B
 It must be a specialist paediatric ethics committee
C
 It must have at least 10 members
D
 There is no additional requirement

Question Number 4:
Under what circumstances would you conduct pharmacokinetic clinical trials in healthy children?
A
 You wouldn't - this is unethical
B
 Only in children over the age of 13
C
 Only if the product will only be used in children
D
 Only if a specialist panel agrees it is necessary

Question Number 5:
According to ICH GCP should children be asked to sign the consent form?
A
 No
B
 Only if they are over the age of 13
C
 Only if the investigator feels it is appropriate
D
 Yes if they are capable and a legal representative has given consent

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