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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: What is the purpose of....?

Question Number 1:
According to ICH GCP chapter 8 what is the purpose of filing the Insurance Statement?
A
 To document that the investigator will be indemnified in the event of legal action by any subject
B
 To document that compensation to subjects for trial-related injury will be available
C
 To document that the sponsor has obtained adequate insurance
D
 There is no requirement to file the Insurance Statement

Question Number 2:
According to ICH GCP chapter 8 what is the purpose of filing the CV of the investigator?
A
 To document who is acting as investigator
B
 To document qualifications, education and training of the investigator
C
 To document qualifications and eligibility to conduct trial and/or provide medical supervision of subjects
D
 There is no requirement to file the investigator's CV

Question Number 3:
According to ICH GCP chapter 8 what is the purpose of filing the IRB/IEC composition?
A
 To document that the IRB/IEC is constituted in agreement with GCP
B
 To document who was present at the meeting which reviewed the protocol
C
 To document which IRB/IEC has reviewed the protocol
D
 There is no requirement to file the IRB/IEC composition

Question Number 4:
According to ICH GCP chapter 8 what is the purpose of filing the Certificate of Analysis of investigational products shipped?
A
 To document identity, purity and strength of investigational products to be used in the trial
B
 To document shipment of investigational product to the site
C
 To document authorisation to use the investigational product for the trial
D
 There is no requirement to file the Certificate of Analysis

Question Number 5:
According to ICH GCP chapter 8 what is the purpose of filing the pre-trial monitoring report?
A
 To document that the monitor visited the site before the trial commenced
B
 To document that the trial procedures were reviewed with the investigator and the investigator's staff
C
 To document that the site is suitable for the trial
D
 There is no requirement to file a pre-trial monitoring report

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