Drug Evaluation Committee 2019-16 Electromagnetic Retention of Materials to be Preserved by Clinical Trial Review Committees
Related classification: record keeping
Initial release date: Jul 2019
Revised publication date: Apr 2024
Question.
Our hospital has had a clinical trial management office for 10 years. The warehouse where we store related materials is becoming full, and we are wondering if it would be possible to digitize the materials.
We would like to keep the documents stored at the site and those stored by the investigator on paper, but we are considering whether we can save the documents to be kept by the Clinical Trial Review Committee in PDF format, as stipulated in Article 34 of the GCP. When I asked a pharmaceutical company about this, they told me that it would be possible if the clinical trial review committee meeting itself was held using electronic documents, but since the paper-based documents are the originals, it would be problematic to save the PDF versions of those documents. What is the Pharmaceutical Manufacturers Association's view on this?
The Pharmaceutical Manufacturers Association of Japan (PMAJ)'s view
Regarding the handling of the case where materials to be preserved by a clinical trial review committee are preserved as electromagnetic records (electronic records, etc.) in lieu of preservation of written documents, Article 2, Article 4 of the "Ministerial Ordinance on the Use of Information and Communications Technology for the Preservation of Documents by Private Business Operators, etc. under the Laws and Regulations of the Ministry of Health, Labor and Welfare (Ministerial Ordinance of the Ministry of Health, Labor and Welfare No. 44 of March 25, 2005)" is applicable. Article 4, Paragraph 2 of the "Ministerial Ordinance on the Use of Information and Communications Technology in the Preservation of Documents by Private Business Operators, etc. under the Laws and Regulations Governing the Ministry of Health, Labour and Welfare (Ordinance of the Ministry of Health, Labour and Welfare No. 44 of March 25, 2005) The method of converting written documents into electromagnetic form by using a scanner (including equivalent image-reading devices) is permitted under Article 4, Paragraph 2 of the "Ministerial Ordinance (MHLW Ministerial Ordinance No. 44 of March 25, 2005)".
Therefore, as long as the above ministerial ordinance is complied with, there is no problem in storing documents to be preserved by the investigational review committee in electromagnetic records, but the electromagnetic records must have "authenticity," "readability," and "preservation. In order to ensure these three principles, please note the contents described in the "Partial Amendment to the Basic Policy on the Use of Electromagnetic Records in Clinical Trial Documents (July 1, 2014, Ministry of Health, Labor and Welfare, Pharmaceutical and Food Safety Bureau, Office Communication)" and the following document from the Japan Pharmaceutical Manufacturers Association (JPMA).