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如何提高药品上市后监测的效率,降低研究成本,是进行药物监测研究必须考虑的问题。日本京都大学医学部附属医院开发了与医院电子病历系统相结合的数据采集系统,应用于药品上市后监测。结合医院电子病历的数据采集系统的应用,可避免传统临床研究中纸质版病例报告表的填写,有效降低药品上市后监测的成本,提高研究监测数据的质量。国内的相关研究也可考虑应用这种方法的可行性。本文对该系统进行介绍,以期为国内研究者提供参考。
How to improve the efficiency of post-marketing drug monitoring and reduce the cost of research is a problem that must be considered in drug monitoring research. The Affiliated Hospital of Kyoto University, Japan developed a data collection system that combines with the hospital’s electronic medical record system to monitor post-marketing of drugs. Combined with the application of hospital electronic medical records data acquisition system, the paper-based case report form can be avoided in traditional clinical research, the cost of post-marketing monitoring can be effectively reduced, and the quality of research monitoring data can be improved. Relevant domestic research may also consider the feasibility of applying this method. This article describes the system, with a view to providing reference for domestic researchers.