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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 Audits

Question Number 1:
Which of the following does ICH GCP define as the purpose of a sponsors audit?
A
 To evaluate trial conduct and compliance with the protocol and other requirements
B
 To evaluate trial conduct and compliance with the protocol, SOPs, GCP and the applicable regulatory requirements
C
 To determine whether the appropriate regulations and guidelines are being followed correctly
D
 To ensure the integrity of the data and the safety of the trial subjects

Question Number 2:
What does ICH GCP state about how to preserve the independence and value of an audit?
A
 Audits should be performed by individuals independent of the sponsor organisation
B
 Audit reports should not be made available to trial personnel
C
 Regulatory authorities should not routinely request the audit reports
D
 Audits should be performed by more than one individual

Question Number 3:
What does ICH GCP state about how an auditor should be qualified?
A
 by a either a bioscience degree, a nursing or medical qualification or similar
B
 by training in SOPs, regulatory guidelines and the protocol
C
 by training and experience to conduct audits properly
D
 by relevant experience as a Monitor

Question Number 4:
Which of the following is not in the list given by ICH GCP for the factors guiding the audit plan and procedures for a trial audit?
A
 importance of the trial to submissions to regulatory authorities
B
 number of subjects in the trial
C
 type and complexity of the trial
D
 duration of treatment for each trial subject

Question Number 5:
According to ICH GCP when should a sponsor provide an audit certificate?
A
 Always
B
 Whenever an audit has been completed successfully
C
 When requested
D
 When required by applicable law or regulation

 
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