医院药物临床试验免费检验信息系统改进的探讨与实践

Discussion and Practice on the Improvement of Drug Clinical Trial Free Laboratory Information System in Hospital

关键词:  药物临床试验  药物临床试验质量管理规范  检验信息系统

Key words:  drug clinical trial(DCT)  good clinical practice(GCP)  laboratory information system(LIS)

摘要:

目的 通过建立契合医院实际的药物临床试验（drug clinical trail，DCT）免费检验信息系统（laboratary information system，LIS），方便研究医师开展实施DCT，体现药物临床试验质量管理规范内涵要求。方法 结合医院现行的诊疗流程，了解医院普通医嘱组套的实施过程。与信息科工程师沟通DCT医嘱组套的实现形式以及在系统中与普通医嘱的区别点。并通过前期试运行的结果，逐步改进和完善医院的DCT免费LIS。结果 建立了适合医院的DCT免费LIS，降低了临床医师开具实验室检查单的差错率，提高了试验项目中的检验检查正确率，减少了检验检查的缺漏项。结论 电子免费LIS与纸质检验检查申请单相比，在准确度、结果回报和溯源方面都具有优势。

Abstract:

OBJECTIVE Through the establishment of a free drug clinical trial(DCT) management system in accordance with the actual situation of hospital, it is convenient for investigators to carry out DCT and meet the connotation of good clinical practice. METHODS Combined with the current diagnosis and treatment process of hospital, understood the implementation process of the general medical order. Communicated with the information engineer the realization form of DCT medical order set in hospital information system, designed the differences between the general medical set and the DCT medical order set. And through the test of the DCT laboratory information system(LIS), improved the DCT free LIS in hospitals. RESULTS A DCT free LIS in hospital was established, which could significantly reduce the error rate of researchers' laboratory checklist, improve the correct rate of laboratory items and reduce the missing items involved in DCT. CONCLUSION Compared with manual process, the electronic DCT free LIS has obvious advantages in accuracy, return on results, and traceability.