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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: Informed Consent - Subject Information

Question Number 1:
According to ICH GCP the information for clinical trial subjects should include: "That the trial involves XXXXXXX"
A
 use of unlicensed medication
B
 additional tests and procedures
C
 research
D
 payment to the investigator

Question Number 2:
According to ICH GCP the information for clinical trial subjects should include: "The alternative procedure(s) or course(s) of treatment that may be available to the subject, and XXXXXXX"
A
 their important potential benefits and risks
B
 the consequences of non-participation
C
 the importance of the research
D
 the likelihood of their success

Question Number 3:
According to ICH GCP the information for clinical trial subjects should include: "The anticipated XXXXX, if any, to the subject for participating in the trial
A
 risks
B
 prorated payment
C
 expenses
D
 both B and C

Question Number 4:
According to ICH GCP the information for clinical trial subjects should include: "The trial treatment(s) and XXXXXX"
A
 benefits
B
 the probability for random assignment to each treatment
C
 blinding procedures
D
 comparator products

Question Number 5:
According to ICH GCP the information for clinical trial subjects should include: "That the subject or the subject's legally acceptable representative will XXXXX"
A
 be required to sign the consent form
B
 have a responsibility to inform the investigator of any change of circumstances affecting the subject's ability to participate in the trial
C
 be informed in a timely manner if information becomes available that may be relevant to the subject's willingness to continue participation in the trial
D
 be required to maintain confidentiality regarding the trial and the subject's participation in the trial

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