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

The correct answer is - A. Report this as a serious adverse event (SAE).

Explanation:

A serious adverse effect (SAE) is a condition that can cause a threat to the patient's life or functioning. As here the research site staff becomes aware and knows of a participant's death searching through public records it is called  a serious adverse effect (SAE).

Thus, the correct answer is - A. Report this as a serious adverse event (SAE).

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