Drug Evaluation Committee 2017-27 Handling of Signed Consent Forms Digitized by Scanner (Part 2)
Related classification: Record keeping
Date of first publication: October 2017
Question
This is a question regarding the electronic storage of consent documents. In all clinical trials at our hospital, the procedure for storing various consent documents is to add the following three points in the corner of the original paper consent document and submit it to the department in charge of electronic medical record storage (Medical Information Section, Medical Affairs Division).
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(1)Number indicating each department
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(2)Medical record ID
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(3)Date consent was obtained
(1), (2), and (3) are stored as digitized documents in the electronic medical record as they are written. Paper media will eventually be discarded after scanning is completed. The consent document is a photocopy, and the photocopy is given to the subject as the subject's copy after the subject and the physician have completed the entry date and signed the document respectively.
If we store the document electronically according to our hospital's procedure, (1), (2), and (3) will be added to the subject's copy, and I think that "authenticity" will not be maintained.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The case in question seems to be a process in which a certified copy is made by electromagnetic method and stored instead of the paper copy of the signed consent document that is stored by the implementing medical institution. In this process, it is sufficient to be able to show that the electromagnetically generated copy is equivalent to the original paper copy of the signed consent document kept by the implementing institution, and it is not necessary to show that it is equivalent to the original document kept by the subject.
For the purpose of management at the site, there is no problem in adding some information to the signed consent document as long as the original information is not compromised, and there is no problem for the site to store the original or certified copy of the document in accordance with your hospital's procedures.
The fact that the consent document is in the form of a photocopy ensures that the portion stored at the site and the portion stored by the subject are equivalent at the time the consent is obtained.