Free Access RAPS.RAC-US.v2022-01-21.q33 Practice Test (Page 4)

Question 11

The intermediate manufacturing process was changed during development of a pharmaceutical. The change may impact the API specification. Which functional area is responsible for the final approval of the change?

A.Regulatory

B.Production

C.Quality

D.Analytical

Question 12

You discover that your company's top selling product in the last two years has been used off-label.
The off-label use is estimated to be about 70%, and it has been consistent since the product was first released to the market. Which of the following is MOST appropriate?

A.Discuss with regulatory authorities to investigate how to have the off-label indication approved.

B.No action is required since it is an off-label use.

C.Advise the senior management to send a "Dear Dr." letter.

D.File a report to regulatory authorities and advise the marketing department to prevent future off-label use.

Question 13

During several monitoring visits, a clinical trial monitor identifies serious and repeated noncompliance on the part of the PI. What action should the sponsor take?

A.Inform the institution that granted a medical license to the Pi.

B.Increase the frequency of monitoring visits.

C.Terminate the PI and inform the regulatory authorities.

D.Send a letter of complaint to the Ethics Committee that approved the site.

Question 14

The regulatory authority in Country X issued a request for a mandatory product recall in
Country X due to serious injuries to patients. This product also is distributed in Country Y.
What should the regulatory affairs professional of the product's manufacturer FIRST do in
Country Y?

A.Draft a formal letter to customers in Country Y about this recall.

B.Initiate a mandatory recall of the product in Country Y.

C.Review alt distribution records and complaints reported in Country Y.

D.Prepare the legal team in Country Y for possible litigations.

Question 15

According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?

A.Malfunction protection operated correctly

B.Malfunction occurring before the end of service life of the medical device

C.Adverse event caused by patient conditions

D.Deficiency of a device found by the user prior to patient use

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