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最新的 RAC Regulatory Affairs Certification RAC-US 免費考試真題:
1. A regulatory authority announces an inspection of a regulatory affairs professional's facility during a holiday season when most of the staff Is not available. What is the MOST practical approach to this dilemma?
A) Inform the authority that the time is not suitable and request a new time
B) Insist that key personnel be available for the inspection.
C) Negotiate with colleagues and the authority to find a better time.
D) Arrange for an inspection without all intended personnel.
2. In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation.
However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?
A) Inform the regulatory authority that such a requirement is not applicable to the product.
B) Inform the internal departments to redesign the product to comply with this requirement.
C) Discuss with the regulatory apriority and attempt to reach an acceptable solution.
D) Notify senior management that the product cannot be registered.
3. According to ICH, which of the following components of study information is NOT required in a clinical study report?
A) List of lECs or lRBs
B) Detailed CV of all investigators
C) Protocol and protocol amendments
D) Randomization scheme and codes
4. When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
A) Phase I and II clinical trials
B) Phase III clinical trials
C) Pre-clinical studies
D) Phase I clinical trials
5. Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?
A) Subject's hospitalization is due to an unscheduled hip operation.
B) Subject is hospitalized due to complications of the product administration.
C) Subject's hospitalization is prolonged during the clinical trial.
D) Subject is hospitalized for the purpose of product administration.
問題與答案:
問題 #1 答案: C | 問題 #2 答案: C | 問題 #3 答案: B | 問題 #4 答案: B | 問題 #5 答案: D |
106.37.168.* -
太驚喜了,你們的考試練習題和答案真的很好,我就這樣輕松的通過了 RAC-US 考試,而且價格也非常合理!