Drug Evaluation Committee 2014-30 English translation of the original document
Related classification: Other
Date of first publication: November 2014
Question
In a certain international clinical trial, because the case report forms in EDC are written in English, the source documents, the medical records, are also required to be written in English. Furthermore, after it was decided that an audit would be conducted, we are being asked to make additions to the medical record, which was written in Japanese.
I think this is strange from the perspective of ALCOA, but the sponsor says it is necessary for consistency between the case report and the source documents. If such a response is mandatory in international clinical trials, I think it will affect the promotion of clinical trials in Japan. Is this necessary?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Just because there is a difference in language (i.e., Japanese notation in the medical record must be translated into English and entered into EDC) does not mean that the case report form is inconsistent (i.e., there is a discrepancy) with the source documents.
When a clinical investigator inputs EDC (English) himself/herself, it is clear that the EDC is read from the medical record (Japanese). On the other hand, when a non-physician investigator transcribes the EDC (English) from the medical record (Japanese), the names of adverse events, history of events/complications, etc. must be translated accurately into English without the intervention of medical judgment by the investigator. One way to achieve this is for the investigator to write both Japanese and English in the medical record in advance.
We do not believe that it is necessary to translate the content of the original medical record into English at a later date solely for the purpose of conducting an audit.