临床试验医学检测费实时结算管理模式探讨

Discussion on the management mode of real-time reimbursement of testing expense in clinical trials

目的探索临床试验医学检测费实时结算管理模式,弥补手工报销的不足,提高工作效率。方法基于现有医院HIS系统,医院药物临床试验机构整合临床试验信息体系,优化试验报销流程,探索出独有的“临床—机构—财务”临床试验实时结算管理途径。结果医院已运用医学检测费用实时结算管理模式3年。该管理模式使受试者在进行缴费前完成临床试验相关医学检测费的减免,受到研究者及受试者的一致好评。此管理模式顺应大数据时代信息化和相关技术的发展,实现了药物临床试验医学检测费的全流程动态监管,避免管控滞后,在简化报销程序、减少工作量、减少错误、提高管理效率、加强监管力度、满足核查要求和提高临床试验质量等方面具有优势。结论临床试验医学检测费实时结算管理模式更好地遵循了GCP,维护了受试者权益,可为其他药物临床试验机构提供一定参考。

Objective To explore the management mode of the real-time reimbursement of testing expenses in clinical trials,dealing with the possible disadvantages of manual reimbursement and improving work efficiency.Methods Based on hospital information system,the GCP center integrates the clinical trial information system,optimizes the trial reimbursement process,and explores a unique"clinic-GCP-finance"streamlined clinical trial real-time settlement management model.Results This management mode of real-time reimbursement of testing expenses havS been adopted for 3 years.This management model enables human subjects to complete the reduction or exemption of clinical trial-related medical testing expenses before making the payments,which is also highly praised by both investigators and subjects.It complied with informatization and technology development in the era of big data,realized full process dynamic supervision over clinical trial lab testing expenses and avoided management delay.It also had advantages in simplifying reimbursement process,reducing work load and mistakes,complying with inspection and improving trial quality.Conclusions Clinical trial real-time reimbursement management mode of testing expenses works better in compliance with GCP,safeguards the rights and interest of human subject,and can provide a certain reference for other GCP centers.