Drug Evaluation Committee 2022-48 Necessity of SAE Reporting at the Time of Hospitalization at the Subject's Request
Related classification: Report of adverse drug reactions, etc.
First published: Apr 2023
Question
During the course of a clinical trial, a subject presented to the Investigator Site with symptoms of AE (diarrhea) and was hospitalized at the subject's strong request. The physician has determined that the event is at a level that allows the subject to go home, and has not determined that the subject "needs to be hospitalized for treatment". In this case, do we need to report it as an SAE?
Although the subject was hospitalized at the subject's request, treatment is being provided for the AE.
I checked the Clinical Trial 119 , 2008-46, and 2022-12, but I could not find a clear answer, so I would appreciate your opinion.
JPMA's Opinion
If the physician has determined that hospitalization for treatment is not necessary and the subject is hospitalized at the subject's request (hospitalization for convenience), this does not constitute a serious adverse event (SAE). The decision is based on whether or not the treatment required hospitalization or prolonged hospitalization, not on whether or not the treatment was provided in the hospital.
Please note that the circumstances leading to these judgments must be read correctly from the source documents.