摘要
药物临床试验信息化管理对临床试验数据和质量的控制起着至关重要的作用。国内临床试验资料数据的“纸质化”,是导致临床试验效率低、质量难控制和精力浪费的重要原因。通过探讨药物临床试验机构研究者资质、立项审查和试验经费的电子信息化管理以及临床试验流程中的受试者、试验药品、生物样本、临床试验数据电子信息化管理的需求,促进国内临床试验中电子化数据管理系统的开发和应用,为构建符合国内《药物临床试验质量管理规范》需求的临床试验信息化管理系统提供支持。
The drug clinical trial management plays a crucial role in the control of clinical trial data and quality.The“paper quality”of clinical trial data is an important reason for the low efficiency,hard quality control and energy waste of clinical trials.By exploring the qualifications of researchers in drug clinical trial institutions,electronic information management of project review and trial funding,and the need for electronic information management of subjects,test drugs,biological samples,and clinical trial data in clinical trial procedures,the development and application of the electronic data management system in China provides support for the construction of the clinical trial management system that meets the domestic GCP requirements.
作者
郭作兵
昝莹
GUO Zuo-bing;ZAN Ying(Office of the Institute of Clinical Drugs Trials,Peking University Care Luzhong Hospital,Shandong Province,Zibo 255400,China)
出处
《中国当代医药》
2020年第14期175-177,共3页
China Modern Medicine
基金
山东省重点研发计划(公益性科技攻关类)项目(2018GSF118130)。
