Question

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

Answer 1

Answer:

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).