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Weekly GCP Challenge

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Challenge: Ethics Committees in ICH GCP

Question Number 1:
According to ICH GCP when reviewing clinical trials IRBs/IECs should pay special attention to trials that may include what?
A
 Vulnerable subjects
B
 Placebo control
C
 Gene Therapy
D
 Medication which has no therapeutic benefit for subjects

Question Number 2:
According to ICH GCP how long should an IRB/IEC take to review a protocol and document its opinion?
A
 60 days
B
 A reasonable time
C
 90 days
D
 No longer than 6 months

Question Number 3:
According to ICH GCP what is the miminum number of members which should be present for an IRB/IEC meeting to be quorate?
A
 3
B
 4
C
 40% of members
D
 There is no specified number

Question Number 4:
According to ICH GCP which types of Adverse Events should the investigator promptly report to the IRB/IEC?
A
 All Adverse Drug Reactions
B
 All Serious Adverse Drug Reactions
C
 All Unexpected Serious Adverse Drug Reactions
D
 All Unexpected Serious Adverse Events

Question Number 5:

Which of the following does ICH GCP say the IRB/IEC should notify the investigator of in writing?

a) Its trial-related decisions/opinions

b) The reasons for its decisions/opinions

c) Procedures for appeal of its decisions/opinions
A
 a, b and c
B
 a and b only
C
 a only
D
 a and c only

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