From the Guidelines
The correct answer is C. 24 hours. Site staff should report an unexpected serious adverse event (SAE) to the Sponsor within 24 hours after becoming aware of the event, as emphasized in the study published in Stroke 1. This rapid reporting timeline is critical in clinical trials to ensure patient safety and allow sponsors to quickly evaluate potential risks. The 24-hour reporting requirement for SAEs is a fundamental Good Clinical Practice (GCP) standard that helps maintain trial integrity and participant protection. Some key points to consider when reporting SAEs include:
- Death: an event that results in the death of a subject
- Life-threatening: an event that, in the opinion of the investigator, would have resulted in immediate fatality if medical intervention had not been taken
- Inpatient hospitalization: an event that results in admission to a hospital for any length of time
- Prolongs hospitalization: an event that occurs while the study subject is hospitalized and prolongs the subject’s hospital stay
- Persistent or significant disability/incapacity: an event that results in a condition that substantially interferes with the activities of daily living of a study subject, as outlined in the study 1. This timeframe allows sponsors to assess whether immediate action is needed, such as notifying other research sites, implementing additional safety monitoring, or even considering trial modifications. The urgency reflects the serious nature of these events, which may include life-threatening conditions, hospitalizations, or other significant medical occurrences that could impact the risk-benefit assessment of the investigational product.
From the Research
Reporting of Serious Adverse Events
- Site staff should report an unexpected serious adverse event (SAE) to the Sponsor within a specific timeframe.
- The correct option is not directly stated in the provided evidence, as the studies focus on various medical topics and do not address the reporting of SAEs.
- However, according to general guidelines for Good Clinical Practice (GCP), site staff should report unexpected SAEs to the Sponsor within 24 hours after becoming aware of the event 2, 3, 4, 5, 6 are not relevant to this question.
- Based on standard practices, the most likely correct answer is:
- C. 24 hours
- Note that the provided studies do not directly support this answer, but it is a common requirement in clinical trials.