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RAPS RAC-US Exam
Regulatory Affairs Certification (RAC) US (Page 6 )

Updated On: 19-Jan-2026
Page 4 of 21
PDF with 100 Questions

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

  1. Subject is hospitalized due to complications of the product administration.
  2. Subject is hospitalized for the purpose of product administration.
  3. Subject's hospitalization is due to an unscheduled hip operation.
  4. Subject's hospitalization is prolonged during the clinical trial.

Answer(s): B



Which of the following is NOT required to be included in a marketing application?

  1. Final printed label
  2. Quality, safety, and efficacy Information
  3. Administrative forms
  4. Evidence of fee payment

Answer(s): D



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?

  1. Contact the trade association for advice.
  2. Communicate with the relevant internal departments.
  3. Prepare documents for the files.
  4. Request a permanent waiver from the new regulation.

Answer(s): B



A process is ultimately validated to ensure which of the following?

  1. The process meets the regulatory requirements.
  2. The process meets the quality system requirements.
  3. The process consistently produces the desired results.
  4. The process consistently meets the desired Quantity standards

Answer(s): C



One month prior to the anticipated approval date for your product, the marketing application that you submitted to a major regulatory authority has become the subject of an advisory committee meeting of experts convened by the regulatory authority. The advisory committee members unanimously vote not to approve your product because of a safety concern. Two days after the advisory committee meeting, the regulatory authority requests additional information to support the safety of your product. Assuming you have no additional data to provide, which of the following would be your MOST appropriate response to the regulatory authority's request?

  1. "Given the advisory committee's unanimous decision, we know that the product will not be approved, and additional data will not make any difference."
  2. "We have no additional information to provide at this time, but we can perform an additional analysis for a specific safety concern, if necessary."
  3. "We disagree with the advisory committee's decision because the committee neglected the thorough safety analysis that we provided."
  4. "We have no additional information to provide at this time because we have already provided everything needed to support our product's approval."

Answer(s): B



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