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目的拟解决药物临床试验纸质化管理中数据采集慢、核查和质量控制滞后、试验周期长、临床试验用药物管理不规范等问题。方法研究建立了适用于局域网络环境下的药物临床试验信息化管理系统,并将其应用到药物临床试验管理中。结果该系统具有用户管理、数据填写与统计、质量控制和药物管理等功能,对药物临床试验各参与人员进行合理分配和有效监管,具有很好的实用价值。结论系统的应用规范了药物临床试验的整个流程,提高了临床试验的管理效率,保证了试验结果的真实性和准确性。
Objective To solve the problems in the paper-based management of drug clinical trials such as slow data collection, laggard verification and quality control, long test period and non-standard drug administration in clinical trial. Methods The study established a clinical trial information management system suitable for local area network environment and applied it to the management of clinical trials of drugs. Results The system has such functions as user management, data filling and statistics, quality control and drug administration. It has a good practical value for rational distribution and effective supervision of all involved participants in drug clinical trials. Conclusion The system application standardizes the whole process of drug clinical trials, improves the management efficiency of clinical trials, and ensures the authenticity and accuracy of test results.