信息化系统对药物临床试验质量的影响

Effect of information system on the quality of drug clinical trials

目的探讨信息化系统对药物临床试验质量的影响。方法介绍本院药物临床试验信息化系统的功能,选取本院信息化系统使用前2015年1月-2016年12月期间入组受试者353例,信息化系统使用后2017年1月-2018年8月期间入组受试者295例,收集质控及监查记录,对比信息化系统使用前后各类关键问题发生率,并进行系统满意度问卷调查,分析信息化系统的优势及不足。结果使用信息化系统优化了机构管理流程,显著降低访视超窗、数据溯源、合并用药、安全性事件记录与报告及试验药物管理方面的问题发生率。结论信息化系统有助于规范药物临床试验流程,提高药物临床试验质量。

Objective To explore the influence of information system on the quality of clinical trials. Methods The functions of the information system of drug clinical trial in our hospital were introduced. Totally 353 subjects enrolled from January 2015 to December 2016 before the use of the information system in our hospital were included. After the use of the information system, 295 subjects enrolled between January 2017 and August 2018 were included. The quality control and audit records were collected, the incidence of various key problems before and after the use of the information system was compared, and the system satisfaction questionnaires were conducted. The advantages and disadvantages of the information system were analysed. Results The management of the organization was optimized by the information system, which significantly reduced the incidence of problems concerning window visiting, data tracing, drug combination, safety record and report, and management of experimental drugs. Conclusion The information system helps standardize the clinical trial process of drugs and improve the quality of drug clinical trials.