医院临床试验管理系统的研究与实践

目的 顺应临床试验管理信息化潮流,构建符合机构实际需求的系统平台,提升综合管理水平,保证临床试验合规、高效、有序进行.方法 从临床试验运行的实际需求出发,以项目线上审批、受试者免费医嘱和试验用药品管理为切入点,并基于医院信息系统平台现状进行规划,设计并搭建了一套符合GCP和本院SOP的临床试验管理系统.结果 经过3年左...

Research and practice of hospital clinical trial management system

Objective Along with the trend of clinical trial management informationization,a hospital clinical trial management system would be built to meet the actual demand of medical institution and improve the synthetical management's level for ensuring the compliant,efficient,orderly conduct of clinic trial.Methods Departing from the actual requirement of clinical trial implementation,taking online approval,free advice and drug management as the breakthrough point,and planning based on the hospital information system platform status,clinical trial management system is designed and developed,according to the Good Clinical Practice and hospital Standard Operating Procedures.Results After about three years,over seventy projects of application,the system has completed preliminary building,and especially made ground-breaking progress with realizing subject free advice and real-time management of project funding.Conclusion The smooth running of clinical trial management system in our hospital is helpful for medical institution to realize unified,standardized and professional management of clinical trial.The design and operation of this software system provides a reference example for other hospitals to implement information management of clinical trials.