Final answer:
A study subject breaking a leg in a skating accident qualifies as a Serious Adverse Event (SAE) since it likely necessitates hospitalization and could lead to significant disability, fulfilling the criteria for an SAE in clinical research.
Step-by-step explanation:
Based on the provided information, the incident in question—a study subject breaking his leg in a skating accident—can be considered a Serious Adverse Event (SAE) if the study is a clinical trial. The definition of an SAE in the context of clinical research is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or causes a congenital anomaly/birth defect.
Since the subject broke his leg, which likely required hospitalization and might lead to significant disability or incapacity during recovery, the event falls under the criteria for an SAE. Thus, the answer can be:
a) Yes, this qualifies as a Serious Adverse Event (SAE).