Drug Evaluation Committee Withdrawal of SAE Report to Implementing Healthcare Organizations 2010-10
Related classification: Adverse drug reaction reports
First published: Jun 2010
Question
An adverse event that occurred at the site was reported in writing to the site as an SAE, but was later found not to be an SAE. When we checked the necessary procedures with the clinical trial office, we were told that no specific procedures were required.
Of course, ideally, it would be better to report the withdrawal again to the investigational review board (IRB) using the SAE report form. However, if the hospital responds that no procedures are required, there is no report to the IRB, but the results of the IRB's deliberations on previous SAE reports will not be affected, and the record of the withdrawal (revision) of the SAE on the CRF by DCF will remain in the hospital, so the explanation can be made clearly even afterwards. For the above reasons, we do not think that any problem will arise even if the in-hospital procedure is unnecessary.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If an event that was reported as a serious adverse event (SAE) in an individual case is determined not to be an SAE due to subsequent progress, etc., we think it is desirable to report that to the investigator and the head of the site. On the other hand, a request for deliberation by the investigational review committee is not required if the head of the site determines that it is unnecessary.
However, if the clinical trial protocol or explanatory documents are revised due to the event, or if some instructions are issued when the investigational review committee discusses the event, and these revisions or instructions are no longer applicable (because the event does not constitute an SAE), the investigational review committee should be asked to discuss the event again. If the Clinical Trial Review Committee issues any instructions when it deliberates on the event or the event in question, and these revisions or instructions no longer apply (because the event in question is not an SAE), it is necessary to request the Clinical Trial Review Committee to deliberate again.