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·药事管理·

        基于药物临床试验项目管理系统的受试者诊疗模块的实现与评

        价  Δ


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        王肖雲 ，邵 欣 ，杨 扬 ，郭志明 ，张子寅 ，席 晨 ，张小高 ，连军营 ，张晓坚 ，高剑波 ，李郁鸿（1.郑州
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        大学第一附属医院临床试验机构 ，郑州 450002；2.郑州大学第一附属医院信息处，郑州 450002；3.北京诺铭
        科技有限公司，北京 100094）
        中图分类号 R951；R969.4         文献标志码      A      文章编号     1001-0408（2021）13-1537-06
        DOI  10.6039/j.issn.1001-0408.2021.13.01
        摘  要   目的：为药物临床试验中的受试者诊疗方案的构建提供参考。方法：我院基于药物临床试验项目管理系统（CTMS）开发
        及实施了受试者诊疗模块，并评价其效果。结果：我院在CTMS内建立了受试者诊疗模块，自2019年10月中旬上线起1年内，该
        模块的受试者库中组内人数整体呈递增趋势，同时整体受试者脱落率均值为0.16％；建立了CTMS系统和医院信息系统（HIS）、实
        验室信息管理系统、医学影像信息系统等的数据接口，实现了受试者信息同步（在HIS系统中显示受试者标识）、诊疗信息和计费
        数据（患者与受试者分别单独计费）的交互。自该模块上线后，接口产生的数据量整体呈递增趋势，产生受试者诊疗业务的科室数
        量逐月递增；与基于 HIS 系统的受试者诊疗项目比较，基于 CTMS 系统的受试者诊疗业务数量显著增多（P＜0.05）。结论：基于
        CTMS的受试者诊疗模块提高了受试者诊疗项目实施和财务结算的效率，实现了药物临床试验项目在大型综合性医院的高效实施。
        关键词 药物临床试验；药物临床试验项目管理系统；受试者诊疗模块

        Implementation and Evaluation of Subject Diagnosis and Treatment Module Based on Drug Clinical Trial
        Management System
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        WANG Xiaoyun ，SHAO Xin ，YANG Yang ，GUO Zhiming ，ZHANG Ziyin ，XI Chen ，ZHANG Xiaogao ，LIAN
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        Junying ，ZHANG Xiaojian ，GAO Jianbo ，LI Yuhong（1. Clinical Trial Institution，the First Affiliated Hospital
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        of Zhengzhou University，Zhengzhou 450002，China；2. Information Office，the First Affiliated Hospital of
        Zhengzhou University，Zhengzhou 450002，China；3. Beijing Nuoming Technology Co.，Ltd.，Beijing 100094，
        China）
        ABSTRACT    OBJECTIVE：To provide reference for the construction of subject diagnosis and treatment scheme in drug clinical
        trials. METHODS：The subject diagnosis and treatment module was developed and implemented in our hospital on the basis of
        CTMS，and its effects were evaluated. RESULTS：A subject diagnosis and treatment module was established in CTMS of our
        hospital. Within one year from the launch of the module in the middle of October，2019，the overall number of subjects in the
        group showed an increasing trend，and the overall mean dropout rate of subjects was 0.16％. The data interface of CTMS system，
        hospital information system （HIS），laboratory information management system，medical imaging information system had been
        established，so as to realize the synchronization of subject information（displaying subject identification in HIS system）and the
        interaction of diagnosis and treatment information and billing data（patients and subjects were charged separately）. Since the launch
        of the module，the amount of data generated by the interface had been increasing，and the number of departments producing the
        subject diagnosis and treatment business had been increasing month by month. Compared with subject diagnosis and treatment
        project based on HIS system，the number of subject diagnosis and treatment business based on CTMS system was increased
        significantly（P＜0.05）. CONCLUSIONS：The subject diagnosis and treatment module based on CTMS improves the efficiency of
        subject diagnosis and treatment project implementation and financial settlement，and realizes the efficient implementation of drug
        clinical trial projects in large general hospitals.
        KEYWORDS    Drug clinical trials；Clinical trial management system；Subject diagnosis and treatment module

                                                               目前，我国药物临床试验行业正处在高速成长期，
           Δ 基金项目：重大新药创制科技重大专项（No.2020ZX09201009）
           ＊主管药师，硕士。研究方向：药物临床试验管理与研究。电话：                   而信息化技术是临床试验高效运行的有力手段。2020
        0371-66295624。E-mail：xiaoyunwang_zzu@hotmail.com   年4月28日，国家药品监督管理局和国家卫生健康委员
           # 通信作者：主任药师，硕士生导师。研究方向：临床药学。电                   会发布《药物临床试验质量管理规范》（GCP）修订版，肯
        话：0371-66295624。E-mail：zhxj0524@sina.com           定了药物临床试验信息化新技术的使用，支持临床试验


        中国药房    2021年第32卷第13期                                             China Pharmacy 2021 Vol. 32 No. 13  ·1537 ·
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