Free Access RAPS.RAC-US.v2022-09-26.q36 Practice Test (Page 3)

Question 6

A request was received from a regulatory authority asking the company to conduct product testing in compliance with a newly issued regulation.
What should be done. What action should the company take FIRST?

A.Consult with colleagues about the request.

B.Initiate testing immediately to ensure compliance.

C.Send a letter back to the regulatory authority indicating why the regulation does not apply to the product.

D.Contact the regulatory authority that issued this request and discuss the requirement.

Question 7

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.Terminate the PI and inform the regulatory authorities.

B.Increase the frequency of monitoring visits.

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

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

Question 8

A company is developing a new product for the global market. A new international guideline will recommend relevant studies in the pediatric population, and the guideline will be effective before the approval of the company's new product.
What is the BEST advice the regulatory affairs professional can provide to minimize the impact of this guideline on the successful registration of the new product?

A.The new guideline has no impact on the current registration plan since all relevant registration studies are almost completed.

B.The company should consult with relevant regulatory authorities to determine the potential impact on the current registration plan.

C.The company should initiate the required pediatric studies immediately to avoid costly delays to the current registration plan.

D.The new guideline has no impact on the current registration plan, but the company must be prepared to defend its decision.

Question 9

Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?

A.Subject's hospitalization is prolonged during the clinical trial.

B.Subject's hospitalization is due to an unscheduled hip operation.

C.Subject is hospitalized due to complications of the product administration.

D.Subject is hospitalized for the purpose of product administration.

Question 10

Which of the following BEST describes the process of post-marketing surveillance for healthcare products?

A.Vigilance procedure to notify the regulatory authorities about serious incidents

B.Systematic procedure to review published scientific journals

C.Vigilance procedure to ensure the full traceability of the products

D.Systematic procedure to review experiences with the products in use

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