Drug Evaluation Committee 2010-52 Necessity of a List of Signatures and Imprints in Clinical Trials Using Electronic CRFs
Related classification: Other
First published: Apr 2011
Revised publication date: Mar. 2012
Question
The necessity of a list of signatures and impressions in clinical trials using electronic CRFs (eCRFs) has been based on the sponsor's opinion.
- Not required when electronically signing the eCRF and storing a copy in an electronic medium such as CD-ROM (however, required when the DCF exists in paper form).
- Necessary when the eCRF is printed out and signed by the investigator, etc. on the cover page.
We received the above remarks during an audit of a clinical trial in which a list of signatures and seals had not been prepared. We would like to pay attention to this issue in the future.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The list of signatures and impressions is a document intended to supplement the authenticity of the name, seal, or handwritten signature of the investigator to certify that he or she has prepared, changed, or revised the case report form. Therefore, when preparing a paper case report form, it is necessary to prepare a list of signatures and impressions.
On the other hand, when electronic signatures are used instead of handwritten signatures, as in the case of EDC, it is not necessary to prepare a list of signatures and impressions as is done for paper case report forms. In this case, as indicated in "4. Requirements for the Use of Electronic Signatures" of "Application for Approval or Licensing of Drugs, etc., Using Electromagnetic Records and Electronic Signatures" (Pharmaceutical and Food Safety Bureau Director-General Notification No. 0401022 dated April 1, 2005), a separate measure to ensure the reliability of electronic signatures is required. As indicated in "4. Requirements for the Use of Electronic Signatures" in "4.
Reason for revision of opinion
In accordance with the revision (October 24, 2011) of the "Implementation of Standards for Conducting Clinical Studies on Pharmaceuticals", "seal" was changed to "imprint".