Free Access RAPS.RAC-US.v2022-09-26.q36 Practice Test (Page 5)

Question 16

According to ICH, which of the following components of study information is NOT required in a clinical study report?

A.Protocol and protocol amendments

B.Detailed CV of all investigators

C.Randomization scheme and codes

D.List of lECs or lRBs

Question 17

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 18

During routine surveillance, a regulatory authority sent a company the following communication: "Hepatotoxicity and suicidal behavior were identified as potential safety issues for the company's product. The regulatory authority is evaluating these issues to determine the need for any regulatory action." Which action would be the most appropriate
FIRST step for the company to take?

A.Contact the regulatory authority to argue that its conclusions are wrong.

B.Wait for the regulatory authority's final publication on its findings.

C.Repeat the Hepatotoxicity tests and send the results to the regulatory authority.

D.Contact the regulatory authority to discuss its findings.

Question 19

In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?

A.Safety and efficacy

B.Compatibility and safety

C.Efficacy and material

D.Volume and material

Question 20

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.Biological activity with species and/or tissue specificity

B.Proposed product route and frequency of administration

C.Proposed dose and volume of administration

D.Immunochemical and functional tests

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