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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: GCP Essential Documents 2

Question Number 1:
According to ICH GCP where would the Samples of Labels attached to investigational product containers be filed?
A
 Investigator Site File
B
 Sponsor File
C
 Both
D
 Neither

Question Number 2:
According to ICH GCP where would the Shipping Records for Investigational Products and Trial Related Materials be filed?
A
 Investigator Site File
B
 Sponsor File
C
 Both
D
 Neither

Question Number 3:
Which of the following need(s) to be on file before the trial can start?
A
 Agreement
B
 Indemnity
C
 Insurance
D
 All of them

Question Number 4:
According to ICH GCP which of the following is the odd one out in terms of where it/they should be filed?
A
 Audit Certificate
B
 Master Randomisation List
C
 Monitoring Visit Reports
D
 Subject Identification Code List

Question Number 5:
According to ICH GCP, why should the essential documents be maintained during a trial?
A
 So the files are ready for inspection
B
 So important documents do not get lost
C
 So new relevant information is documented as it becomes available.
D
 So we show that we are following our SOPs

 
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