WEB-BASED RAC-US PRACTICE TEST WITH DUMPS

Web-based RAC-US Practice Test With Dumps

Web-based RAC-US Practice Test With Dumps

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To be eligible to take the RAC-US exam, candidates must have a minimum of three years of regulatory experience in the healthcare industry. Candidates may also be eligible if they have a combination of education and experience that meets the requirements set forth by RAPS. RAC-US Exam consists of 120 multiple choice questions and is administered over a four-hour period. Candidates who pass the exam earn the RAC designation, which demonstrates their expertise and commitment to regulatory affairs in the healthcare industry.

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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q35-Q40):

NEW QUESTION # 35
In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?

  • A. Efficacy and material
  • B. Volume and material
  • C. Safety and efficacy
  • D. Compatibility and safety

Answer: D


NEW QUESTION # 36
In which section of the ICH Common Technical Document will the overview of clinical data appear?

  • A. Module 1
  • B. Module 3
  • C. Module 2
  • D. Module 4

Answer: C


NEW QUESTION # 37
Why is it necessary to run supplemental safety pharmacology studies?

  • A. To substitute the utilization of GLP
  • B. To provide adverse reaction reports and the results of the statistical data to the regulatory authority
  • C. To comply with regulatory authority requirements related to clinical studies
  • D. To evaluate potential adverse pharmacodynamics effects not addressed by the core battery

Answer: D


NEW QUESTION # 38
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. Inform the institution that granted a medical license to the Pi.
  • C. Send a letter of complaint to the Ethics Committee that approved the site.
  • D. Increase the frequency of monitoring visits.

Answer: A


NEW QUESTION # 39
Which of the following statements regarding the off-label use of drugs is CORRECT?

  • A. The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing access to much needed drugs and devices.
  • B. Although the regulatory authority reviews and approves drugs for specific indications, the approval does not limit the use of those drugs in clinical practice.
  • C. The regulatory authority does not restrict physician prescribing for off-label indications or regulate the manufacturer's promotion for such use.
  • D. Sponsors are allowed to distribute publications about unapproved uses of approved drugs and devices as long as the marketing application is under review by the regulatory authority.

Answer: B


NEW QUESTION # 40
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