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GCP Tests

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.

Test: Ethics Committees (2)

Question Number 1:
According to EU legislation, for how long should the Ethics Committee keep documentation?
A
 Until the final study report is issued
B
 2 years after the last marketing authorisation
C
 3 years after the end of the clinical trial
D
 5 years after the end of the clinical trial

Question Number 2:
According to EU Legislation how often should an Ethics Committee review study progress?
A
 It depends on the study
B
 At least once per year
C
 At least once during the study
D
 As decided by the Ethics Committee

Question Number 3:
Which of the following would NOT be considered a lay person for the purposes of Ethics Committee membership?
A
 A nurse
B
 An accountant
C
 A clergyman
D
 A social worker

Question Number 4:
According to EU legislation, which one of the following is NOT required to be reviewed by the Ethics Committee?
A
 The Investigator's Brochure
B
 A poster advertising the study which will be displayed at the trial site
C
 The payment to the investigator
D
 The CRF

Question Number 5:
According to EU legislation, what is the timeline for notifying the Ethics Committee if a study is terminated early?
A
 7 days
B
 15 days
C
 30 days
D
 90 days

 
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