中药注射剂安全性医院集中监测研究数据管理内容与要点

Contents and Key Points of Data Management During Hospital Centralized Monitoring of the Safety of Traditional Chinese Medical (TCM) Injections

按照中药注射剂安全性再评价相关要求,中药注射剂安全性医院集中监测研究陆续展开。安全性集中监测研究属于大规模真实世界研究,涉及到大量数据的采集、传递、核查和分析。数据采集和数据核查的质量,直接影响数据分析和研究结果的真实性和可靠性。因此,数据管理是中药注射剂安全性集中监测研究的重要环节。在分析前期相关研究的基础上,结合项目实施的经验和体会,本文探讨了中药注射剂安全性集中监测研究数据管理实施内容、环节及常出现的问题及相应的解决方法。

According to the related requirements of safety reevaluation of TCM injections, hospital centralized monitoring of the safety of TCM injection was consecutively pressed ahead. Centralized security monitoring was a large-scale real world research involving numerous data acquisition, transmission, verification and analysis. The quality of data acquisition and data verification directly affected the authenticity and reliability of research data and results. Therefore, data management played a significant role in the safety monitoring of TCM injections. Based on the analysis of previous researches, this paper discussed the implementation content, links and the frequent problems and corresponding solutions of data management during the safety monitoring of TCM injections, combining with the experience in the implementation of projects.