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Listening Quiz: Thảo Luận về Thời Hạn Báo Cáo Biến Cố Bất Lợi – Medium Level
Th12 4, 2024
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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.
Within how much time must serious adverse events be reported?
Within 30 days
Within 2 weeks
Within 24 hours
Within 7 days
Explanation:
Sophia says that serious adverse events must be reported within 24 hours.
2.
What form do they use for these reports?
A custom incident report
The standard pharmacovigilance form
An email template
A patient feedback survey
Explanation:
Sophia states that they use the standard pharmacovigilance form.
3.
Who reviews the reports after submission?
The finance department
The legal department
The safety team
The study participants
Explanation:
Sophia explains that the safety team reviews all reports immediately after submission.
4.
What can be inferred about late reporting of adverse events?
It does not require notifying anyone
It may cause serious consequences for the study
It only affects non-serious events
It is unlikely to matter if the report is eventually submitted
Explanation:
Sophia says late reporting can lead to fines or study suspension, so it may cause serious consequences for the study.
5.
What is the main purpose of the conversation?
To evaluate the safety team’s performance
To discuss deadlines and procedures for reporting adverse events
To train David on how to use a new computer system
To decide which study participants should be contacted
Explanation:
The conversation focuses on reporting timelines, forms, review procedures, and consequences for late reporting.
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