| Against the backdrop of rapid advances in life sciences and deepening international scientific collaboration, this study explores optimization strategies for the digital management of human genetic resources. The research addresses the distinctive challenges in oncology research, including diverse types of human genetic resource specimens, close correlation with clinical data, frequent cross-border collaborative activities, and stringent regulatory compliance requirements. A national key research and development program undertaken by the hospital was selected as the case studyto explore the development of a “one-stop digital management system for human genetic resources.” Based on an international collaborative NSCLC research project, a one-stop management system was developed covering project initiation, ethics review, human genetic resource approval, sample and information management, research output management, and post-project traceability. By mapping the project’s management objects, operational processes, and major risk pointsand embedding human genetic resource regulatory requirements into the full life-cycle management process, this study provided a systematic design for cross-departmental coordination, process documentation, and risk alerts. The feasibility to cover the principal management needs of international collaborative research projects has been primarily shown in this study which also has been registered as a copyrighted software. Due to compatibility issues with other electronic management systems of the hospital, this system is currently adopted only for trial use in this case. Its improvements on hospital-wide approval efficiency, communication costs and risk control performance will be quantitatively evaluated in subsequent practical applications. |
