Quiz: An introduction to drug development and ethics

Which of the following is not an objective of a Phase IV study?

Using a cross-over design increases the required sample size.

Which of the following is not a randomization method?

For an individual to be included in the per protocol set, which of the following conditions need to be satisfied?

Testing the difference between two means, determine the total sample size for α = .05 if power is required at 0.8 when ∆ = 0.2, and the standard deviation for both groups is assumed to be 1.

If a drug is registered (accepted) by a local European authority, it is automatically accepted in all other European countries?

What is considered as research integrity?

In which year did ICH-GCP become the gold standard for clinical trials?

Ethical Review of clinical research is fundamental to…

Which of the following sentences are correct?

Who is blinded in a double blind study?

Which of the following endpoints are clinical relevant?