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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: ICH GCP - Filing Essential Documents

Question Number 1:
According to ICH GCP where would you file the Final Trial Close-out Monitoring Report?
A
 Sponsor Trial Master File Only
B
 Investigator Trial Master File Only
C
 Both the Sponsor and Investigator Trial Master Files
D
 Neither the Sponsor or Investigator Trial Master Files

Question Number 2:
According to ICH GCP where would you file the Routine Monitoring Visit Reports?
A
 Sponsor Trial Master File Only
B
 Investigator Trial Master File Only
C
 Both the Sponsor and Investigator Trial Master Files
D
 Neither the Sponsor or Investigator Trial Master Files

Question Number 3:
According to ICH GCP where would you file the Original Signed, Dated and Completed Case Report Forms?
A
 Sponsor Trial Master File Only
B
 Investigator Trial Master File Only
C
 Both the Sponsor and Investigator Trial Master Files
D
 Neither the Sponsor or Investigator Trial Master Files

Question Number 4:
According to ICH GCP where would you file the Signed Informed Consent Forms?
A
 Sponsor Trial Master File Only
B
 Investigator Trial Master File Only
C
 Both the Sponsor and Investigator Trial Master Files
D
 Subject Medical Notes Only

Question Number 5:
According to ICH GCP where would you file the Signature Sheet that documents signatures and initials of all persons authorised to make entries and/or corrections on CRFs?
A
 Sponsor Trial Master File Only
B
 Investigator Trial Master File Only
C
 Both the Sponsor and Investigator Trial Master Files
D
 Neither the Sponsor or Investigator Trial Master Files

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