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Verdich
2 months ago
11

A participant missed several study visits and the research site staff becomes aware of a participant's death searching through p

ublic records. What is the most appropriate next course of action?
A. Report this as a serious adverse event (SAE).

B. Report this as an adverse event (AE).

C. No action is required.

D. Contact the Study Physician for instructions on next steps
Medicine
1 answer:
bonufazy [81]2 months ago
3 0

Answer:

The right choice is - A. This should be reported as a serious adverse event (SAE).

Explanation:

A serious adverse event (SAE) refers to a condition that poses a significant risk to a patient’s life or their ability to function. In this case, it becomes classified as a serious adverse effect (SAE) as the research site staff learned of a participant’s passing through public records.

Therefore, the right choice is - A. This should be reported as a serious adverse event (SAE).

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