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To be eligible to take the RAC-US exam, individuals must have at least two years of regulatory affairs experience and a bachelor's degree in a related field. The exam is offered twice a year and is available in both online and paper-based formats.

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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q17-Q22):

NEW QUESTION # 17
A materials supplier informs a company that it intends to stop supplying a material critical to the manufacture of the company's products. What action should the company take FIRST?

  • A. Review the company's existing Quality Management System
  • B. Reformulate the products with a replacement material.
  • C. Complete a gap analysis to identify options.
  • D. Qualify another supplier and execute a supplier agreement.

Answer: D


NEW QUESTION # 18
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.

Answer: A


NEW QUESTION # 19
A global company is developing a sophisticated implantable medical device that is coated with antibiotics and biologics to enhance its efficacy.
The product is marketed in Country X.
where it is regulated as a medical device.
The same product, without the antibiotics and biologics, is marketed as a medical device in Country Y.
The company is proposing to start marketing the coated device in Country Y.
Which regulatory approach should the company propose?

  • A. Examine decisions made about similar products in Country Y to propose the classification of the product.
  • B. Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.
  • C. Submit the product for review as a pharmaceutical product in Country Y.
  • D. Apply for review of the additional part of the product as a pharmaceutical product in Country

Answer: D


NEW QUESTION # 20
Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?

  • A. Subject is hospitalized for the purpose of product administration.
  • B. Subject's hospitalization is prolonged during the clinical trial.
  • C. Subject's hospitalization is due to an unscheduled hip operation.
  • D. Subject is hospitalized due to complications of the product administration.

Answer: A


NEW QUESTION # 21
In order to develop a global drug product, what is the MOST important environmental characteristic to consider in the country of intended use?

  • A. Product requirements
  • B. Product registration
  • C. Product formulation
  • D. Product stability

Answer: D


NEW QUESTION # 22
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