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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: ICH Trial Results Related Definitions

Question Number 1:

According to ICH E9 what is the following the definition of?

"The systematic tendency of any factors associated with the design, conduct, analysis and evaluation of the results of a clinical trial to make the estimate of a treatment effect deviate from its true value."
A
 Violations
B
 Drop Outs
C
 Deviations
D
 Bias

Question Number 2:

According to ICH E9 what is the following the definition of:

"A variable that provides an indirect measurement of effect in situations where direct measurement of clinical effect is not feasible or practical."
A
 Composite endpoint
B
 Surrogate endpoint
C
 Secondary endpoint
D
 Predictive endpoint

Question Number 3:

According to ICH E9 what is the following the definition of:

"The set of data generated by the subset of subjects who complied with the protocol sufficiently to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of major protocol violations."
A
 All Randomised Set
B
 Intention to Treat Population
C
 Per Protocol Set
D
 Safety Set

Question Number 4:

According to ICH E9 what is the following the definition of:

"The extent to which the findings of a clinical trial can be reliably extrapolated from the subjects who participated in the trial to a broader patient population and a broader range of clinical settings."
A
 Treatment Effect
B
 Label Claim
C
 Generalisability
D
 Representability

Question Number 5:

According to ICH E9 what is type of Bias is the following the definition of:

"Bias introduced through deviations in trial conduct"
A
 Statistical
B
 Operational
C
 Observer
D
 Selection

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