最新なRAPS RAC-GS問題集（100題）、真実試験の問題を全部にカバー！

質問 1：
You discover that your company's top selling product in the last two years has been used off-label. The off-label use is estimated to be about 70%, and it has been consistent since the product was first released to the market. Which of the following is MOST appropriate?
A. File a report to regulatory authorities and advise the marketing department to prevent future off-label use.
B. Discuss with regulatory authorities to investigate how to have the off-label indication approved.
C. No action is required since it is an off-label use.
D. Advise the senior management to send a "Dear Dr." letter.
正解：B

質問 2：
In which section of the ICH Common Technical Document will the overview of clinical data appear?
A. Module 1
B. Module 4
C. Module 2
D. Module 3
正解：C,D

質問 3：
The safety database for an anti-hypertensive drug consists of the following:
461 patients exposed for three months
343 patients exposed for six months
112 patients exposed for nine months
74 patients exposed for 12 months
Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?
A. 3.000 total patient exposures
B. 100 patients for 12 months
C. 500 patients for three months
D. 200 patients for nine months
正解：B

質問 4：
As a member of the product launch review committee, a regulatory affairs professional discovers a major issue with the labeling of a product prior to production. In addition to informing the committee, which is the BEST approach to address the issue?
A. Correct the label text.
B. Delay the start of product production.
C. Abort the product launch.
D. Inform the regulatory authorities.
正解：D

質問 5：
A company is developing a novel drug to combat AIDS. The preliminary results are very promising and include instances of complete remission. The company has been granted patents in multiple countries for the drug. The regulatory affairs professional is asked to prepare a brief report concerning potential problems for marketing of the product worldwide. Which of the following is the MOST important consideration to discuss?
A. The time frame in which the patent will expire
B. Doha Declaration in the TRIPS Agreement
C. The stability of the drug in all zone conditions
D. International import and export regulations
正解：C

質問 6：
Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?
A. Quality by design analysis
B. Failure modes, effects, and criticality analysis
C. Fault tree analysis
D. Fishbone analysis
正解：B

質問 7：
According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?
A. Class D
B. Class C
C. Class A
D. Class B
正解：B

質問 8：
Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?
A. Proposed dose and volume of administration
B. Immunochemical and functional tests
C. Biological activity with species and/or tissue specificity
D. Proposed product route and frequency of administration
正解：C

質問 9：
According to ISO 14971,what is the FIRST step when developing a risk management plan for a medical device?
A. Risk analysis
B. Risk management
C. Risk control
D. Risk estimation
正解：A