Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

What items should be submitted to the Sponsor if a subject has a suspected serious adverse drug reaction with the outcome of death?

1. A de-identified autopsy report and cause of death

2. Summary of clinical trial results and participant feedback

3. Only the participant's medical history

4. A report from the research site's ethics committee

The correct answer is: A de-identified autopsy report and cause of death

Submitting a de-identified autopsy report and the cause of death is essential when dealing with a suspected serious adverse drug reaction that has resulted in a subject's death. Such documentation provides critical information about the circumstances surrounding the death, particularly the nature and potential impact of the reaction on the subject's health. The autopsy report offers detailed insights into any underlying health conditions or contributing factors that may clarify the relationship between the drug and the death. Identifying the cause of death is crucial for assessing whether the adverse reaction was indeed related to the investigational drug, which is vital for ensuring participant safety and regulatory compliance. In contrast, the other options do not provide the necessary direct information regarding the adverse event itself. Summaries of clinical trial results and feedback from participants might capture broad trends or sentiments but lack the specific details needed in this serious situation. A participant's medical history, while valuable, does not substitute for the direct evidence from an autopsy regarding the adverse event's outcome. Finally, a report from the research site's ethics committee would reflect ethical oversight processes but would not furnish the scientific or medical details necessary for evaluating the serious adverse event.