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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q31-Q36):

NEW QUESTION # 31
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 peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing access to much needed drugs and devices.
• C. Although the regulatory authority reviews and approves drugs for specific indications, the approval does not limit the use of those drugs in clinical practice.
• D. The regulatory authority does not restrict physician prescribing for off-label indications or regulate the manufacturer's promotion for such use.

Answer: C
NEW QUESTION # 32
Which of the following is the PRIMARY purpose of an audit report?

• A. To carry out a complete review of product applications
• B. To define how to prepare new product submissions
• C. To train sales representatives
• D. To document compliance history

Answer: D
NEW QUESTION # 33
The requirements for document control are located in which of the following documents?

• A. WHO guidelines
• B. ICH guidelines
• C. ISO 13485
• D. IEC 60601

Answer: C
NEW QUESTION # 34
A clinical study of a drug is completed to support a marketing approval application.
According to ICH, how long should a sponsor retain the clinical study essential documents?

• A. Three years after the last clinical study site was supplied with investigational drugs
• B. Until the product has been discontinued from marketing in all ICH regions
• C. For a minimum of 10 years after completion of the clinical study
• D. For at least two years after the last approval of an application in an ICH region

Answer: D
NEW QUESTION # 35
What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?

• A. Ask the vendor to take responsibility.
• B. Request documentation from the sub-contractor.
• C. Document and perform audits.
• D. Request an inspection from a regulatory authority.

Answer: C
NEW QUESTION # 36
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