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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 - Monitor's Responsibilities

Question Number 1:
In ICH GCP which of the following is NOT listed under monitor's responsibilities
A
 Verifiying that the investigator is enroling only eligible subjects
B
 Verifying that written informed consent was obtained
C
 Verifying that consent was obtained by a physician
D
 Reporting the subject recruitment rate

Question Number 2:
In ICH GCP which of the following is the monitor NOT required to check in CRFs
A
 Data required by the protocol are consistent with source documents
B
 Any dose and/or therapy modifications are well documented
C
 That the investigator has initialled and dated every page of the CRF
D
 They are required to check all of these

Question Number 3:

Which of the following is the monitor required to check for IMP?

1. Storage times and conditions

2. Subjects are provided with the necessary instructions

3. The investigational product is supplied only to subjects eligible to recieve it

4. Receipt use and return are controlled and documented

5. Disposition of unused IMP complies with applicable requirements
A
 1, 3, 4 and 5
B
 All of them
C
 1,2, 3 and 4
D
 1, 3 and 4

Question Number 4:
Which of the following most accurately describes the monitor's responsibility in ICH GCP regarding site staff training?
A
 The monitor should provide training in the protocol
B
 The monitor should only recruit clinical trial sites with previous training in GCP
C
 The monitor should ensure that the investigator and the investigator's trial staff are adequately informed about the trial
D
 The monitor should ensure that at least one person from the trial site attends protocol specific training

Question Number 5:
In ICH GCP what is the recommended timeline for the monitor to write the monitoring report?
A
 As soon as possible
B
 No longer than 6 months
C
 Within a reasonable time
D
 There is no recommendation regarding the timeline

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