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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: Clinical Trial Design 3

Question Number 1:

In a randomisation scheme using blocks what is the next allocation?

A, B, B, A, B, A, A, ?

A
A
B
B
C
C
D
It is not possible to tell

Question Number 2:
In a cross over trial it is essential to ensure that no effect of the first treatment phase carry over into the second treatment phase. To minise the chance of this happening what is generally included in the design?
A
elimination phase
B
wash out period
C
recovery period
D
placebo period

Question Number 3:

Using a telephone based system for randomisation, product supply or diary cards is often referred to as IVRS...but what does IVRS stand for?

A
Interactive Voice Response System
B
Interactive Voice Recognition System
C
Interactive Voice Registration System
D
Interactive Voice Recording System

Question Number 4:

You have designed a parallel group clinical trial that requires more subjects than you have budget for. Which of the following options (subject to certain limitations based on therapeutic area and indication) could help reduce your required sample size?

a) change to a cross over trial

b) reduce the expected difference between treatments

c) refine the entry criteria to reduce outcome variance

d) reduce the power of the trial

A
a and b only
B
a, b and c only
C
a, b and d only
D
a, c and d only

Question Number 5:

"In general, pregnant women should be excluded from clinical trials where the drug is not intended for use in pregnancy. If a patient becomes pregnant during administration of the drug, treatment should generally be discontinued if this can be done safely."

This is a statement from the ICH E Guidelines........but which one?

A
E2
B
E3
C
E6
D
E8

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