From the Guidelines
The correct answer is D. Severity. When determining whether expedited reporting to the FDA by the Sponsor is required for an adverse event, the severity of the event is not a determining factor. Instead, the FDA requires expedited reporting based on three key criteria: seriousness (whether the event threatens life or function), expectedness (whether the event is listed in the investigator brochure or is unexpected), and causal relationship with the study product (whether the event is possibly related to the investigational product) 1.
According to the FDA definition of serious adverse event, it includes death, life-threatening event, initial or prolonged hospitalization, disability, congenital anomaly or an adverse event requiring intervention to prevent permanent impairment or damage 1. Severity, which refers to the intensity of an adverse event (mild, moderate, severe), is important for documentation purposes but does not trigger expedited reporting requirements.
The definition of serious adverse events is further clarified in another study, which lists specific examples of serious adverse events, including death, life-threatening events, inpatient hospitalization, and persistent or significant disability/incapacity 1. However, severity is not mentioned as a criterion for expedited reporting in either of these studies.
Therefore, the severity of an adverse event is not a determining factor for expedited reporting to the FDA, and clinical research professionals should focus on the criteria of seriousness, expectedness, and causal relationship with the study product when determining reporting requirements 1.
From the Research
Adverse Event Features
- The features used to determine whether expedited reporting to the FDA by the Sponsor is required include:
- Seriousness (threatening life or function)
- Expectedness
- Causal relationship with study product
- Severity is not a determining factor for expedited reporting, but rather a descriptor of the adverse event itself 2, 3, 4, 5
Expedited Reporting Requirements
- Expedited reporting is required for serious, unexpected adverse events that are causally related to the study product
- The FDA requires sponsors to report such events in a timely manner, typically within 15 calendar days of becoming aware of the event
- The reports must include detailed information about the event, including the subject's identification number, the adverse event term, and the outcome 4, 5
Adverse Event Assessment
- Adverse events are assessed for their seriousness, expectedness, and causal relationship to the study product
- The assessment is typically based on the information available at the time of the report, and may be updated as additional information becomes available
- The sponsor is responsible for determining whether an adverse event meets the criteria for expedited reporting 2, 3, 6