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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
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| 篇名： | 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 |
| TITLE： | Implementation and Evaluation of Subject Diagnosis and Treatment Module Based on Drug Clinical Trial Mana- gement System |
| 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。 |
| ABSTRACT： | OBJECTIVE：To provide reference for the c onstruction 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. |
| 期刊： | 2021年第32卷第13期 |
| 作者： | 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 |
| AUTHORS： | WANG Xiaoyun，SHAO Xin，YANG Yang，GUO Zhiming， ZHANG Ziyin，XI Chen，ZHANG Xiaogao，LIAN Junying，ZHANG Xiaojian，GAO Jianbo，LI Yuhong |
| 关键字： | 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 |
| KEYWORDS： | Drug clinical tr ials；Clinical tr ial management system ；Subject diagnosis and treatment module |
| 阅读数： | 440 次 |
| 本月下载数： | 8 次 |
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