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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: ICH GCP Monitoring

Question Number 1:
According to ICH GCP Section 5.18 Monitoring, which of the following is not stated under the section entitled Selection and Qualification of Monitors
A
 Monitors should be appointed by the sponsor.
B
 Monitors should be thoroughly familiar with the safety reporting procedures of the trial and should ensure the training is documented and updated on a regular basis.
C
 Monitors should be thoroughly familiar with the investigational product(s), the protocol, written informed consent form and any other written information to be provided to subjects, the sponsor’s SOPs, GCP, and theapplicable regulatory requirement(s).
D
 Monitors should be appropriately trained, and should have the scientific and/or clinical knowledge needed to monitor the trial adequately. Amonitor’s qualifications should be documented.

Question Number 2:
According to ICH GCP Section 5.18 which of the following is not stated as one of the determinants of the extent and nature of monitoring?
A
 blinding
B
 endpoints
C
 phase
D
 size

Question Number 3:
What is missing from the following statement in ICH GCP Section 5.18 Monitoring: XXXXXXXXXXX on-site monitoring, before, during and after the trial.
A
 There is always a requirement for
B
 It is essential to perform
C
 In general there is a need for
D
 It is not required to perform

Question Number 4:
What does ICH GCP Section 5.18 Monitoring suggest is may be an acceptable method for selecting the data to be verified?
A
 The opinion of the monitor
B
 The requirements of the sponsor
C
 Random sampling
D
 Statistically controlled sampling

Question Number 5:
How does ICH GCP Section 5.18 describe the situation when central monitoring in conjunction with with procedures such as investigators training and meetings, and extensive written guidance can assure appropriate conduct of the trial inaccordance with GCP
A
 when time is limited
B
 In exceptional circumstances
C
 In late phase trials
D
 As a minimum

 
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