Drug Evaluation Committee 2008-03 Handling of SAE Reporting for Admission for Scheduled Surgery (Part 2)
Related classification: Adverse drug reaction reports
Initial release date: 08/2008
Revised release date: Mar 2021
Question
(Is SAE reporting required once the hospitalization appointment is known?)
During a post-marketing clinical trial, a colonoscopy was performed for the purpose of diagnosing a lack of control of bowel movements, and colon polyps were discovered.
At that time, the gastroenterologist recommended a colon polypectomy.
Subsequently, of his own volition, he made an inpatient appointment for a colorectal polypectomy scheduled after the completion of the examination. The appointment was scheduled more than one month after the completion of the study.
I was told by the monitor that a report would be generated within 24 hours of learning of the hospitalization appointment, which falls under the definition of SAE reporting, hospitalization for treatment, or an extended hospital stay.
I was under the impression that the report was made upon admission to the hospital. I understand your position regarding the scheduled hospitalization in " Question No. 2005-13. Please explain your position on reporting SAEs at the time of knowledge of a planned hospitalization.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 48, paragraph 2 of the GCP states that "When a sponsor requests a clinical trial, the investigator must immediately report to the head of the site and notify the sponsor of the occurrence of death or other serious adverse events suspected to be caused by adverse reactions to the investigational drug. The reason for the difference in opinion with the monitors as stated in your question may be due to the difference in interpretation of "when an occurrence is recognized.
In the case of your question, the issue is whether an "appointment for hospitalization" should be treated as the same as "hospitalization. However, an appointment for hospitalization is just that, an appointment, and it is quite possible that it may be changed depending on the subject's future circumstances. Therefore, it is not necessary to treat it as a hospitalization and judge it as a serious adverse event at this time.
However, as stated in " Question No. 2005-13," the sponsor needs to collect information as promptly as possible in order to determine whether the event should be reported urgently (e.g., whether it was caused by aggravation during the clinical trial). Therefore, if you have information such as the one in question, please provide it to the sponsor as soon as possible.
Reason for revision of opinion
We have changed a part of the statement of opinion in accordance with the revision of the GCP Ministerial Ordinance (Ministry of Health, Labour and Welfare Ordinance No. 155, August 31, 2020) and the GCP Guidance (Pharmaceutical Affairs Agency Announcement No. 0831, August 31, 2020, No. 15).