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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: 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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