Drug Evaluation Committee 2011-50 Handling of Signed Consent Forms Digitized by Scanner
Related classification: Other
Initial release date: March 2012
Revised publication date: December 2021
Question
We received a notice from the implementing medical institution that they introduced electronic medical records in January of this year and scanned the original consent form (for attachment to the medical record) and destroyed it.
The institution treated the scanned PDF as the original (all clinical trial consent forms, OPE consent forms, etc.) and said that they have a policy of not storing paper documents because they believe that storing paper documents would result in double originals (they also believe that this is not in violation of the e-Document Law). As the sponsor of the clinical trial, we repeatedly requested that the consent forms be kept in paper form, but they said that it is the policy of the hospital as a whole and that we cannot be treated specially (paper storage).
We suggested that if the first copy of the consent form is kept at the hospital and the second copy is attached to the medical record, the first copy will remain even if the second copy is scanned into the electronic medical record and destroyed. Is there any problem with the response of the relevant implementing medical institution?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As mentioned in your question, GCP requires the retention of the original consent form signed by the subject, etc. However, it is permitted under the regulations to retain an electronic record created by scanning a paper document (hereinafter referred to as an "electronic document") as the original document in place of the original paper document. However, as stated in the related regulations of the e-Document Law (see below), ensuring the "authenticity," "legibility," and "preservation" of the electronic document is a prerequisite to deeming such electronic document as an original (instead of the original paper document).
Therefore, it is not possible to determine whether or not the original paper document needs to be preserved simply by "digitizing a paper document with a scanner, etc."; rather, it is necessary to check how the "authenticity," "legibility," and "preservation" of the digitized document is ensured (in the case of a medical record-related document, the compliance with the relevant Regulation 2, and in the case of a GCP-related document, the compliance with the relevant Regulation 3). If there is no problem, the medical institution should approve the disposal of the paper originals, or make other decisions on an individual basis.
Related Regulations
1. "Ministerial Ordinance on the Use of Information and Communications Technology in the Preservation of Documents by Private Business Operators, etc. under the Provisions of Laws and Regulations Regulating the Ministry of Health, Labour and Welfare" (March 25, 2005, Ministry of Health, Labour and Welfare Ordinance No. 44)
2. "Guidelines for the Safety Management of Medical Information Systems, Version 5.1" (January 2021, Ministry of Health, Labour and Welfare)
3. "Use of Electromagnetic Records and Electronic Signatures in Applications for Approval or Licensing of Drugs, etc." (April 1, 2005, Pharmaceutical Affairs and Food Safety Bureau, No. 0401022)
Reason for revision of opinion
In accordance with the issuance of the GCP Guidance (July 30, 2021, Pharmaceutical Affairs Bureau of Japan, No. 0730-3), the opinion text has been partially changed.