Drug Evaluation Committee 2013-42 Lost Original SAE Report Form
Related classification: Record keeping
First published: December 2013
Question
A serious adverse event (SAE) occurred at our hospital and the original SAE report form prepared by the investigator was lost in the process of preparing IRB discussion materials. The loss was reported to the investigator, the original was re-created, and the investigator wrote and signed a statement assuring that the re-created version did not differ from the original, which was to be retained with the report.
However, two copies of the original SAE report were prepared, one for the head of the site and the other for the sponsor. The original that was lost this time was addressed to the head of the site, and the original addressed to the sponsor has already been submitted to the sponsor. A copy of the original addressed to the head of the site was also made before the loss of the original.
From the above, I thought again that it was not necessary to make the original again, and that the best solution would have been for the investigator to write and sign on the copy that he/she guarantees that it is identical to the original, and to keep it together with the report. We thought that the original should be made again only when neither the original nor the copy exists at both the site and the sponsor.
Our first priority is to review the handling of the original documents and prevent their loss, but if such a situation should arise, we would like to know what the best course of action would be.
Pharmaceutical Association's Opinion
As long as the content of the SAE report is accurate and the circumstances surrounding the loss of the original and the response can be explained, any of the methods mentioned in your question would be acceptable.