Drug Evaluation Committee 2008-46 Handling of SAE Reporting for Hospitalization for Examination
Related classification: Adverse drug reaction reports
Initial release date: Mar. 2009
Revised publication date: December 2021
Question
A subject participating in a long-term study became aware of angina-like chest pain and was scheduled for hospitalization for cardiac catheterization by the Department of Cardiology. Our hospital's view was that this was not a hospitalization for treatment, but rather a test hospitalization, and that we would consider preparing an SAE report once the test results confirmed the diagnosis of angina pectoris.
The sponsor's side was to report the first report on the SAE report (admission for suspected angina pectoris) at the time of admission for cardiac catheterization, and if the test results did not confirm the diagnosis, the SAE report would be canceled (with the same document and amount of information as the SAE report). As a result, the patient was diagnosed with angina pectoris, but it was difficult for our hospital to understand that the SAE report would be reported withdrawn because treatment was not necessary.
We believe that the above SAE report is unnecessary according to the GCP, but the investigator seems to have a policy of responding to the sponsor's request. Therefore, we would like to accumulate more solid evidence and precedents in order to reply to the sponsor that SAE reports are unnecessary and to convince the investigators that SAE reports are not necessary.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The sponsor is obliged to notify the regulatory authority, the head of the site and the investigator when it becomes aware of Article 80-2, Paragraph 6 of the Pharmaceuticals and Medical Devices Act regarding the study drug, and as one of the items, Article 273, Paragraph 1, Item 2 of the Enforcement Regulations of the Pharmaceuticals and Medical Devices Act states "Admission to a hospital or clinic for treatment One of the items is "cases requiring admission to a hospital or clinic for treatment or prolongation of hospital stay.
In Q36 of the "Revision of Q&A for Post-Marketing Adverse Reaction Reports and Clinical Trial Adverse Reaction Reports in Response to the E2B(R3) Implementation Guide" issued by the Drug Evaluation and Administration Division and Drug Safety Division of the Pharmaceuticals and Consumer Health Bureau of the MHLW, hospitalization for testing is not considered a serious adverse event (hereinafter referred to as SAE). On the other hand, a case in which a patient is hospitalized for treatment of an adverse reaction but no specific treatment is performed (bed rest treatment) is considered an SAE.
Therefore, in a case like the one in question, the key point is the investigator's medical judgment as to whether the subject's hospitalization was accompanied by treatment or not, and the sponsor's judgment as to for what reason it was not accompanied (or accompanied) by treatment. Since the subject developed angina-like chest pain during the trial, it is not considered particularly problematic that the sponsor decided that an SAE report was necessary at the time of hospitalization.
Generally, the timing for reporting the first report is when the hospitalization for treatment is confirmed, but we recommend consultation with the sponsor regarding the decision in specific cases.
Reason for revision of opinion
The referenced clause has been changed in accordance with the revision of the "Q&A on Reporting Adverse Reactions, etc." in the Administrative Instructions.