信息化系统对药物临床试验质量的影响
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摘要
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 August2018 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.
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 August2018 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.
引文
[1]王白璐.药物临床试验质量管理评价研究[D].济南:山东大学,2012.
[2]项玉霞,黄志军,刘畅,等.中国特色药物临床试验机构质量管理体系建设[J].中国临床药理学杂志,2017,33(11):1039-1041.
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[9]杨潇,江红,王永,等.从研究者角度浅谈药物临床试验电子信息化系统应用体会[J].辽宁中医药大学学报,2016,18(6):79-81.
[10]常天瀛,杨海淼,崔英子,等.基于医院信息环境的药物临床试验系统实施与应用[J].长春中医药大学学报,2016,32(5):1050-1053.
[11]朱玉洁,周莉莉,李丽.药物临床试验系统ECTS的构建和特点[J].中国医院药学杂志,2017,37(6):549-552.
[12]王菊勇,肖臻,倪爽,等.我院新型药物临床试验电子信息化管理系统[J].中国新药杂志,2014,23(22):2647-2650.
[2]项玉霞,黄志军,刘畅,等.中国特色药物临床试验机构质量管理体系建设[J].中国临床药理学杂志,2017,33(11):1039-1041.
[3]何高丽,曾涛,张炜,等.药物临床试验数据核查临床部分常见问题的原因分析及控制措施[J].中国新药与临床杂志,2018,37(1):24-28.
[4]国家食品药品监督管理总局.总局办公厅公开征求《药物临床试验质量管理规范(修订稿)》的意见[EB/OL].[2016-12-02].http://samr.cfda.gov.cn/WS01/CL0778/166981. html.
[5]刘金华,刘敏,刘雨村,等.我院药物临床试验实施中方案偏离的回顾性研究[J].中国药房,2017,28(25):3474-3478.
[6]胡薏慧,彭朋,汤洁,等.一种药物临床试验质量评估方法的介绍[J].上海中医药杂志,2016,50(s1):77-79.
[7]程晓华,杨茗钫,刘丽忠,等.临床试验中试验用药品管理模式探讨[J].医药导报,2013,32(5):692-693.
[8]张田香,陆明莹,张彩霞,等.药物临床试验过程中试验用药物管理的关键环节[J].中国新药与临床杂志,2014,33(7):489-491.
[9]杨潇,江红,王永,等.从研究者角度浅谈药物临床试验电子信息化系统应用体会[J].辽宁中医药大学学报,2016,18(6):79-81.
[10]常天瀛,杨海淼,崔英子,等.基于医院信息环境的药物临床试验系统实施与应用[J].长春中医药大学学报,2016,32(5):1050-1053.
[11]朱玉洁,周莉莉,李丽.药物临床试验系统ECTS的构建和特点[J].中国医院药学杂志,2017,37(6):549-552.
[12]王菊勇,肖臻,倪爽,等.我院新型药物临床试验电子信息化管理系统[J].中国新药杂志,2014,23(22):2647-2650.