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最新的 RAC Regulatory Affairs Certification RAC-GS 免費考試真題:

1. Which of the following double-blind clinical trial designs would be MOST appropriate for a Phase III study with a new product intended to treat an acute life-threatening disease with less than optimal available therapy?

A) Cross-over
B) Active-controlled
C) Dose-ranging
D) Placebo-controlled

2. After numerous failed attempts to decrease an identified risk in a medical device to an acceptable level, the medical device continues to have unacceptable risks. However, the development team wants to continue development. Which is the BEST recommendation to make in this situation?

A) Discontinue the project.
B) Redesign the device.
C) Perform another risk-benefit analysis.
D) Add a warning in the IFU.

3. Which of the following is MOST appropriate for the purpose of lot release of biologics?

A) Safety assurance
B) Efficacy confirmation
C) Quality verification
D) Inventory control

4. Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?

A) Failure modes, effects, and criticality analysis
B) Fault tree analysis
C) Quality by design analysis
D) Fishbone analysis

5. Which of the following BEST describes the purpose of the ICH?

A) To protect and promote public health through the evaluation and supervision of safe,effective, and high-quality medicines for the ICH regions
B) To lobby for improved industry standards for the development of new safe, effective, andhigh-quality medicines for the ICH regions
C) To provide scientific evaluation of applications for international marketing authorization forsafe, effective, and high-quality medicines for the ICH regions
D) To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions

問題與答案：