药物临床试验过程中电子支付系统的设计与实践体会  

Design and practice of an electronic payment system in drug clinical trials

作　　者：陈志刚[1] 崔岩峥[1] CHEN Zhi-gang;CUI Yan-zheng(Institute for Clinical Trial,Beijing Jishuitan Hospital,Beijing 100035,China)

机构地区：[1]北京积水潭医院临床试验机构,北京100035

出　　处：《中国新药杂志》2022年第8期784-787,共4页Chinese Journal of New Drugs

摘　　要：目的:构建临床试验过程中的支付平台,使受试者在临床试验过程中及时、准确且合规地获得补助,保障受试者合法权益。方法:采用信息化手段,构建独立于申办者和试验机构的电子支付系统,在保护受试者隐私的前提下,实现在临床试验协调员、项目经理以及试验机构协同监控之下,资金由申办者到支付平台再到受试者的安全转移。结果:经23个试验项目的试行,完成支付798笔,平均支付时限为5.62 d,一次性成功支付率达86.2%,为期1年的试行期间,未见受试者因个人隐私被泄露而产生的抱怨或投诉。结论:该电子支付系统在提高临床试验全流程效率、加强资金使用规范性等方面具有很大优势,为远程监查提供了新的机遇。Objective:To establish a timely,accurate and compliant subsidy payment system for subjects in the process of clinical trials,and to protect the legitimate rights and interests of subjects.Methods:An electronic payment system independent of sponsors and experimental institutions was constructed by information technology.On the premise of protecting the subject’s privacy,the funds were transferred from the sponsor to the payment platform and then to the subjects under the cooperative supervision of the clinical research coordinator,project manager and the trial institution.Results:After 23 pilot projects,798 payments were completed,the average payment time was 5.62 days and the one-time successful payment rate was 86.2%.During the period of one year,there were no complains or complaints caused by the leakage of personal privacy.Conclusion:The electronic payment system has great advantages in improving the efficiency of the whole process of clinical trials and the compliance of fund use,and it provides new opportunities for remote monitoring.

关 键 词：电子支付系统 临床试验 受试者补助 受试者权益 远程监查 

分 类 号：R969.4[医药卫生—药理学]