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

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What is the common term for events that are life-threatening or result in death, requiring immediate reporting?

  1. Adverse Events (AEs)

  2. Serious Adverse Events (SAEs)

  3. Unanticipated Problems

  4. Major Complications

The correct answer is: Serious Adverse Events (SAEs)

The term that specifically refers to events that are life-threatening or result in death, which necessitate immediate reporting, is Serious Adverse Events (SAEs). These events go beyond standard adverse events as they indicate a significant escalation in severity. SAEs require prompt attention and documentation because they pose serious risks to participants' safety and well-being during clinical trials or research studies. In regulatory contexts and clinical research, SAEs often trigger more rigorous procedures for monitoring and reporting, ensuring that appropriate measures can be taken to mitigate risks. Understanding this distinction is critical for maintaining patient safety and adhering to regulatory requirements in clinical research settings.

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