Drug Evaluation Committee 2019-16 Digitization of Records Subject to Retention by the Institutional Review Board
Related Category: Record Retention
Initial Publication Date: July 2019
Revised Publication Date: April 2024
Question
It has been 10 years since our hospital established the Clinical Trials Management Office. The warehouse where we store related documents is becoming full, so we are considering whether it is possible to digitize these documents.
We intend to continue storing the mandatory documents retained by the Investigator Site and the principal investigator in paper form, but we are considering whether we can convert the materials subject to retention by the Institutional Review Board (as specified in Article 34 of GCP) into PDF format for storage.When we raised this issue with a pharmaceutical company, we were told that while it would be possible if the IRB meetings themselves were conducted using electronic materials, since the paper-based materials from meetings held on paper serve as the originals, storing PDFs created from them would be problematic. What is the JPMA’s view on this matter?
JPMA Opinion
Regarding the handling of cases where the documents subject to retention by the relevant Institutional Review Board (IRB) are stored as electronic records (such as digital records) instead of in paper form, Article 4, Paragraph 2 of the “Ministerial Ordinance Concerning the Use of Information and Communications Technology in the Retention of Documents by Private Sector Entities, etc., Based on the Provisions of Laws and Regulations Administered by the Ministry of Health, Labor and Welfare(Ministry of Health, Labor and Welfare Ordinance No. 44 of March 25, Heisei 17).” This ordinance permits the digitization of items recorded on paper using a scanner (including equivalent image-capturing devices), and documents subject to retention under the GCP Ordinance are also covered by this ordinance.
Consequently, provided that the provisions of the aforementioned Ministerial Ordinance are complied with, there is no issue with storing documents subject to retention by the Institutional Review Board (IRB) in the form of electronic records; however, such electronic records must meet the requirements of “authenticity,” “legibility,” and “durability.”To ensure these three principles, please refer to the “Partial Amendment to the ‘Basic Guidelines on the Use of Electronic Records for Clinical Trial-Related Documents’ (Administrative Notice from the Review and Management Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labor and Welfare, July 1, Heisei 26)” and the information contained in the following document from the Japan Pharmaceutical Manufacturers Association.