Drug Evaluation Committee 2017-65 Signatures on Training Records of Clinical Investigators, etc.
Related classification: Other
Date of first publication: February 2018
Question
Is it necessary to match the signatures in Japanese and English on the list of signatures and impressions of investigators and on the training log of physicians (e.g., signatures in Japanese on the list of signatures and impressions and signatures in English on the training log)? We think it is preferable to have the same signatures, but we do not think it is necessary to match the signatures in English and Japanese.
As stated in "2010-52 Necessity of signature and impression list in clinical trials using electronic CRF", the list of signatures and impressions is "a document intended to supplement the authenticity of the name and seal or handwritten signatures used to certify that the applicant has made the preparation, modification, or amendment to the case report form. If the EDC is the sponsor, it is not required to be prepared (the study in charge is the EDC).
In that case, if the sponsor decides that it is not necessary to match, we do not think it is necessary to match the list of signatures and impressions with the training log, etc.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As described in "2010-52: Necessity of signature impression list for clinical trials using electronic CRFs," electronic signatures are used instead of handwritten signatures in electronic CRFs, so there is no need to prepare a signature impression list as is the case with paper CRFs.
On the other hand, the Delegation Log, which is widely used in many countries around the world, requires signatures (including simplified signatures) from investigators and collaborators who are delegated by the principal investigator. The purpose of this is to show that the person in charge has agreed on the scope of his/her responsibility, and also to register the signatures to be used in the clinical trial and to ensure their authenticity.
In countries where seals are not used, it is common practice to use only the preregistered signatures when preparing records related to the clinical trial, similar to how only registered seals are used in Japan.
I assume that your question is whether it is acceptable to use an unregistered signature in the training log when the signature is registered in the signature impression list or the Delegation Log in advance. However, based on the above, we believe that using an unregistered signature for clinical trial-related records is undesirable from the perspective of ensuring the authenticity of the records.
We believe that it is preferable to use a pre-registered signature (simplified signature) for clinical trial records, but please also confirm this with the sponsor.