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Listening Quiz: Thanh Tra Trước Phê Duyệt của FDA tại Cơ Sở Điều Tra – Easy Level
Th4 9, 2025
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bởi
Anna Phạm
trong
Tiếng Anh dành cho Nhà nghiên cứu y học (English for Medical Researcher)
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1.
What does William ask Laura to show him?
The patient discharge records
The laboratory equipment manual
The study budget report
The informed consent forms
Explanation:
William asks, “Can you show the informed consent forms?” and Laura provides the signed forms.
2.
How does Laura describe the study documents?
She says they still need to be organized
She says they are missing several pages
She says she has the files ready
She says they were sent to another office
Explanation:
Laura says, “Sure, I have the files ready for you.”
3.
What does Laura say about the study protocol?
They only followed some of the steps
They followed every step carefully
They have not reviewed it yet
They changed it to improve the results
Explanation:
Laura answers, “Yes, we followed every step carefully.”
4.
According to Laura, were there any deviations or problems during the study?
Yes, there were several small issues
No, because the study was canceled
Yes, but they were quickly fixed
No, everything went as planned
Explanation:
Laura says, “No, everything went as planned.”
5.
What is the conversation mainly about?
A routine FDA pre-approval review at a study site
A request to postpone the research trial
A patient complaint about the clinic
A disagreement over study funding
Explanation:
The conversation centers on William from the FDA reviewing study documents, checking consent forms, and confirming the protocol and study conduct during a pre-approval inspection.
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