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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 - Sponsor Responsibilities

Question Number 1:
According to ICH GCP when should the sponsor update the Investigator's Brochure?
A
 Periodically
B
 According to the sponsor's standard operating procedures
C
 As significant new information becomes available
D
 Annually

Question Number 2:
According to ICH GCP what is the sponsor's responsibility regarding supply of Investigational Products?
A
 To ensure the IP is obtained from a reputable source
B
 To advise the investigator on obtaining IP, supplying it if necessary
C
 To decide whether supplying IP is in the best interests of the trial
D
 To supply IP to the investigator

Question Number 3:
According to ICH GCP which of the following personnel is the sponsor NOT required to designate or appoint?
A
 Administrators
B
 Qualified Medical personnel
C
 Monitors
D
 Auditors

Question Number 4:
According to ICH GCP which of the following is the sponsor responsible for regarding subject notes?
A
 Archiving medical records for subjects in the trial
B
 Verifying that the subjects have consented to direct access for monitoring, etc.
C
 Ensuring subject notes are kept up to date
D
 Amending subject notes in the event of a discrepancy

Question Number 5:
According to ICH GCP what action should the sponsor take in the event of non-compliance by investigational site staff?
A
 Prompt action to secure compliance
B
 Immediate report to the regulatory authority
C
 Legal action against the site
D
 For cause audit

 
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