文件受控管理是近年來藥物臨床試驗管理的熱點(diǎn)和要點(diǎn)，傳統(tǒng)人工文件受控管理效率低，工作量大，本研究設(shè)計了一套全新的文件受控管理系統(tǒng)，通過自動信息化手段為藥物臨床試驗機(jī)構(gòu)文件受控減負(fù)。系統(tǒng)通過C/S通訊模式達(dá)到文檔電子存儲與區(qū)域流轉(zhuǎn)，加入智能檢索功能，解決傳統(tǒng)紙質(zhì)文件不易管理情況，并通過UUID對文件唯一性進(jìn)行標(biāo)識，實現(xiàn)受控管理。通過建立文件受控管理系統(tǒng)，實現(xiàn)紙質(zhì)文件受控管理，初步測試系統(tǒng)功能穩(wěn)定，臨床試驗文件受控工作效率得到提升。電子化文件受控管理可實現(xiàn)用戶賬號追蹤，各操作流程均保留軌跡記錄，實現(xiàn)全流程受控管理，使臨床試驗的開展更加規(guī)范、科學(xué)和有序，值得今后進(jìn)一步推廣應(yīng)用。

Document controlled management is a hot topic and key point in drug clinical trial management in recent years, traditional manual document controlled management is inefficient and requires a large workload, this study designed a new set of document controlled management system to reduce the burden of drug clinical trial institutions by automatic information means. The system achieves electronic storage and regional flow of documents through C/S communication mode, adds intelligent retrieval function to solve the difficulty of paper management, and identifies the uniqueness of documents through UUID to achieve controlled management. By implementing this document controlled management system to achieve the controlled management of paper documents, and also preliminary system test function is stable, leading to improved work efficiency in clinical trial document control. The electronic document controlled management system can track user account, keep track records of each operation process and achieve controlled management of the whole process, which makes the development of clinical trials more standardized, scientific and orderly, and is worthy of further promotion and application in the future.

R951

廣東省醫(yī)學(xué)科學(xué)技術(shù)研究基金項目(A2023474)