综合性医院临床试验免费诊疗信息系统的构建及实施评价
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南京医科大学鼓楼临床医学院科技处

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The Construction and Implementation Evaluation of Free Information System for Clinical Trial in General Hospital
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Gulou clinical medical college, nanjing medical university

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    摘要:

    []目的:构建南京大学医学院附属鼓楼医院国家药物临床试验机构临床试验免费检查信息系统,并对实施现状进行调研分析,以期促进临床试验信息化发展,解决了临床试验受试者免费检查全过程的监管这一难题,为临床试验信息化管理提供参考依据。方法:构建临床试验免费检查信息系统,设计调查问卷,对我院2016年12月参加临床试验的研究者、辅助科室研究者、CRC、机构管理人员等进行以下调研:(1)我院临床试验免费检查信息系统实施实施情况评估;(2)我院临床试验免费检查信息系统工作优势和难点的调查;(3)免费检查信息系统使用人员对我院临床试验信息化发展的意见建议。结果:共发放问卷87份,回收78份,回收率89.7 %,调查显示,大多数研究者已经熟练使用临床试验免费检查信息系统,其中以研究者和CRC使用者居多,在实施过程中,87.18 %的研究者认为通过信息化手段减少了因纸质免费申请单发生的错误,解决了临床试验检查数据溯源难题。但是在实施过程中出现的难点在于,高达60.26 %的研究者认为临床试验免费检查信息系统与新HIS对接存在问题,其中65.38 %研究者希望能够及时解决信息系统存在的问题。结论:临床试验免费检查信息系统的实施,大大优化了受试者检查流程,为研究者做临床试验提供了相当大的便捷,同时有利于临床试验结题经费的核算,实现了药物临床试验免费检查的全流程动态监管,值得今后进一步推广应用,在信息系统实施过程中,希望能够加强临床试验信息化管理的相关培训与沟通协调,同时加快与临床试验药物管理系统和新HIS系统的对接步伐,提高临床试验信息化管理水平。

    Abstract:

    Objective: To build the drum tower hospital affiliated to nanjing university school of medicine, national drug clinical trial institution free inspection information system, clinical trials and research analysis about the present situation of implementation, in order to promote the development of clinical trial information, to solve the clinical trial subjects were free to check the whole process of the problem of regulation, provide reference basis for information management system of clinical trial.Methods: The free examination information system of clinical trial was constructed and questionnaires were designed. The following surveys were conducted on researchers,department researchers, CRC and institutional management personnel who participated in clinical trial in our hospital in December 2016: (1) Evaluation of the implementation of the free examination information system of clinical trial in our hospital;(2) The investigation of the advantages and difficulties of free inspection information system in clinical trial of our hospital;(3) Opinions and Suggestions of free information system users on the development of clinical trial informatization in our hospital.Results: A total of 87 questionnaires, recycling of 78, the recovery rate of 89.7%, according to the survey, most researchers already familiar with clinical trial free inspection information system, in which the majority with researchers and users of the CRC, in the process of implementation, 87.18% of researchers think through informationization means reduced due to the paper application form of error free, solved the difficult problem clinical trial to check data source.However, difficulties in the implementation process lie in the fact that up to 60.26% of researchers believe that there are problems in the docking between the clinical trial free examination information system and the new HIS, among which 65.38% hope to solve the problems in the information system in time.Conclusion: Clinical trial free check the implementation of the information system, greatly optimize the inspection process, participants do clinical trial for the researchers provides a considerable convenience, at the same time, is advantageous to the clinical trial of concluding funds accounting for drug clinical trial free check the whole process of dynamic supervision and worthy of further popularization and application, in the process of information system implementation, to strengthen the related training of the information management system of clinical trial and the communication and coordination, at the same time to speed up with clinical trial drug management system and new ihs docking pace, raise the level of information management system of clinical trials.

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  • 收稿日期:2019-08-16
  • 最后修改日期:2019-10-12
  • 录用日期:2019-12-18
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