治験審査委員会審査用 PDF ファイル自動作成アルゴリズムおよび治験審査委員会支援システムの開発と評価

抄録

The introduction and promotion of information technology (IT) in institutional review boards (IRB) have been a topic of intense discussions. From around 2012, practical examples using tablet devices and cloud systems have been reported. For sponsors and clinical trial offices, introduction of IT has been shown to result in benefits such as shortening of preparation time, reduction of paper waste, and cost reduction. In 2013, the Ministry of Health, Labour and Welfare specified the filename format for electromagnetic records and recommended PDF as the file format in the guidelines for the use of electromagnetic records. We introduced tablet devices and developed operational processes based on the guidelines. For the operation, IRB members pointed out that it was difficult to identify the document contents from the filenames, because there were numerous files and the PDF filenames were coded. To overcome this demerit from IRB members' viewpoint, we have developed four algorithms and an “Institutional Review Board Support System” that improve readability of PDF files and allow completion of operations in a short time. The system is able to merge PDF files in a preset order, convert the coded PDF filename into a format including the document name, and detect filenames not conforming to the guidelines. Using the system, a process that conventionally takes several up to ten hours can be completed in a few minutes. The system can also be applied to tablets devices and cloud systems. We believe the system is helpful in the promotion of IT in IRB.