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Download Regulatory Affairs Certification (RAC) US Exam Dumps
NEW QUESTION 20
A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?
- A. Revision history
- B. Expiration date
- C. Relevance to regulations
- D. Scope and level of detail
Answer: C
NEW QUESTION 21
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 is hospitalized due to complications of the product administration.
- C. Subject's hospitalization is due to an unscheduled hip operation.
- D. Subject is hospitalized for the purpose of product administration.
Answer: D
NEW QUESTION 22
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. Increase the frequency of monitoring visits.
- B. Send a letter of complaint to the Ethics Committee that approved the site.
- C. Inform the institution that granted a medical license to the Pi.
- D. Terminate the PI and inform the regulatory authorities.
Answer: D
NEW QUESTION 23
Which of the following statements regarding the off-label use of drugs is CORRECT?
- A. 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.
- B. The regulatory authority does not restrict physician prescribing for off-label indications or regulate the manufacturer's promotion for such use.
- C. The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing access to much needed drugs and devices.
- D. Although the regulatory authority reviews and approves drugs for specific indications, the approval does not limit the use of those drugs in clinical practice.
Answer: D
NEW QUESTION 24
Which of the following situations does NOT require rapid communication to regulatory authorities?
- A. A major safety finding from a newly completed animal carcinogenicity study
- B. A statistically significant increase in the number of deaths in an animal dose finding study
- C. A lack of efficacy with a medicinal product used in treating a life-threatening disease
- D. A clinically important increase in the rate of occurrence of an "expected." but serious
ADR
Answer: D
NEW QUESTION 25
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