Drug Evaluation Committee 2022-48 Necessity of SAE Reporting at the Time of Hospitalization at the Subject's Request
Related classification: Adverse drug reaction reports
First published: Apr 2023
Question
During a clinical trial, a subject came to the site with symptoms of AE (diarrhea) and was hospitalized at the subject's strong request. The physician in charge judged that the event was at a level that allowed the subject to go home, and did not judge that "hospitalization was necessary 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 they were not clear, so I would appreciate your opinion.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
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.