A participant missed several study visits and the research site staff becomes aware of a participant's death while searching through public records. What is the most appropriate ne... A participant missed several study visits and the research site staff becomes aware of a participant's death while searching through public records. What is the most appropriate next course of action?
Understand the Problem
The question is asking about the appropriate course of action when a study participant has died and this information is discovered by research staff. It is seeking to determine the correct protocol to follow in response to this event based on standard research practices.
Answer
Report the participant's death as a serious adverse event (SAE).
The final answer is to report the participant's death as a serious adverse event (SAE) to the study sponsor and the institutional review board (IRB).
Answer for screen readers
The final answer is to report the participant's death as a serious adverse event (SAE) to the study sponsor and the institutional review board (IRB).
More Information
When a participant in a study dies, it is considered a serious adverse event. Reporting it ensures that all necessary measures are taken to evaluate the impact on the study and maintain compliance with ethical guidelines.
Tips
A common mistake is failing to report the death timely, which can lead to non-compliance with regulatory requirements. It is crucial to act promptly.
Sources
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