Drug Evaluation Committee 2013-42 Lost Original SAE Report
Related classification: Record keeping
Date of first publication: 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, and it was decided that the original SAE report form would be re-created, the investigator would write and sign a statement assuring that the re-created form did not differ from the original, and the original SAE report form would be kept together with the report of the loss.
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.
In view of the above, I thought again that it was not necessary to prepare 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 does not differ from the original, and preserve it together with the report of the incident. 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.
JPMA'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.