Free Access RAPS.RAC-GS.v2022-03-28.q35 Practice Test (Page 7)

Question 26

According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood
glucose self-testing kit?

A.Class A

B.Class D

C.Class B

D.Class C

Question 27

Which of the following double-blind clinical trial designs would be MOST appropriate for a Phase III study
with a new product intended to treat an acute life-threatening disease with less than optimal available
therapy?

A.Placebo-controlled

B.Cross-over

C.Active-controlled

D.Dose-ranging

Question 28

Which of the following criteria is MOST appropriate to define the animal species needed for the
pre-clinical toxicity testing of a biotechnology product?

A.Immunochemical and functional tests

B.Biological activity with species and/or tissue specificity

C.Proposed product route and frequency of administration

D.Proposed dose and volume of administration

Question 29

Following the introduction of a new regulation, an evaluation of the company's products by the regulatory
affairs professional indicates that 60 percent do not comply with the regulation.
What should the regulatory affairs professional do FIRST to meet the new requirement?

A.Request a permanent waiver from the new regulation.

B.Contact the trade association for advice.

C.Communicate with the relevant internal departments.

D.Prepare documents for the files.

Question 30

Which of the following situations does NOT require rapid communication to regulatory authorities?

A.A clinically important increase in the rate of occurrence of an "expected." but serious ADR

B.A lack of efficacy with a medicinal product used in treating a life-threatening disease

C.A statistically significant increase in the number of deaths in an animal dose finding study

D.A major safety finding from a newly completed animal carcinogenicity study

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