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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 - What is the Question?

Question Number 1:

If the answer is "8" then which of these could be the question?

a) The recommended minimum number of members of an ethics committee/IRB

b) The section of GCP that is concerned with Essential Documents

c) The recommended number of years experience a CRA should have before becoming a Senior CRA
A
 a or b only
B
 b or c only
C
 a only
D
 b only

Question Number 2:

According to ICH GCP if the answer to a question is "Investigator" then what could the question be?

a) Who has responsibility for the investigational product accountability at the trial site

b) Who should be able to demonstrate a potential for recruiting the required number of suitable subjects within the agreed recruitment period

c) Who is responsible for the ongoing safety evaluation of the investigational product
A
 a, b or c
B
 a or b only
C
 b only
D
 a only

Question Number 3:

According to ICH GCP if the answer to the question is "Monitoring" what could the question be?

a) Which process is used to verify that the rights and well-being of human subjects are protected

b) Which process is used to verify that the reported trial data are accurate, complete, and verifiable from source documents

c) Which independent process is used to determine whether trial related activities were conducted to the protocol, the SOPs, GCP and the applicable regulatory requirements
A
 a or b only
B
 b or c only
C
 a, b or c
D
 a only

Question Number 4:

According to ICH GCP if the answer to the question is "Sponsor" which of the following could be the question?

a) Who has the responsibility to safeguard the rights, safety and well-being of all trial subjects?

b) Who should ensure the accuracy, completeness, legibility, and timeliness of data reported in the CRFs

c) Who is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs
A
 a only
B
 a or b only
C
 a, b or c
D
 c only

Question Number 5:

According to ICH GCP if the answer to the question is "Investigator Site File" what could the question be?

a) Where would you expect the Subject Enrolment Log to be filed?

b) Where would you expect the Signed Informed Consent Forms to be filed?

c) Where would you expect the Pre-Trial Monitoring Visit Report to be filed if the visit was not combined with the Initiation Visit?
A
 a, b or c
B
 b or c only
C
 b only
D
 a or b only

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