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Challenge: 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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