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

When must Serious Adverse Events (SAEs) be reported to authorities by the sponsor?

1. 24 hours

2. 7 days

3. 15 calendar days

4. 30 calendar days

The correct answer is: 15 calendar days

The requirement to report Serious Adverse Events (SAEs) to authorities is dictated by regulatory standards, particularly for clinical trials. A Serious Adverse Event is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization, results in disability, or is a congenital anomaly. Under these regulations, sponsors are obligated to report SAEs within a specified timeframe to ensure patient safety and regulatory compliance. The correct choice indicates that sponsors must report these events within 15 calendar days. This timeframe ensures that regulatory bodies are informed promptly about significant safety issues that could impact the overall safety profile of a product under investigation. Reporting within this timeframe allows for timely assessments and interventions to protect participating subjects and helps ensure the integrity of clinical trials. In contrast, the other options represent different timeframes that do not align with the established regulations pertaining to SAEs. Understanding the correct reporting timelines is essential for clinical trial management and the broader responsibilities of sponsors in maintaining safety and compliance with regulatory standards.