摘要
新药研究是临床医学研究的重要组成部分,也是衡量一个医院科研能力的重要标志之一。近年来,本院逐步认识到加强药物临床试验的管理,完善质控的重要性。因此,为了规范药物临床试验的开展,提高质量,严格按照国家药监局颁布的GCP的相关规定,严格遵循GCP"安全性和科学性"的原则,并实施了一系列的举措,包括制定完善各项制度及标准操作规程,加强全员的GCP知识和相关技能的培训,并逐步推行"三级质控"制度,加强试验药物的管理等等。本文总结了近几年本院实施开展药物临床试验管理及质控方面的经验及不足,力求在今后的药物临床试验工作的开展中,确保各项操作规范,数据完整准确,充分保护受试者的利益,并不断强化过程管理,提高药物临床试验质量。
Clinical drug trial, it was not only a very important part on clinical medicine research, but a vital remark for evaluating the scientific capability of hospital. The author made a summary about clinical trial management and quality control of clinical drug trial based on the hospital practice in recent years. The paper aimed at enhancing the quality of the drug clinical trial by confirming the standard operation and integrity and accuracy of trial data, protecting the benefit of the subjects, improving the management in process.
出处
《解放军医院管理杂志》
2007年第8期598-599,共2页
Hospital Administration Journal of Chinese People's Liberation Army
基金
上海市科委项目资助(课题编号:04DZ19880)
关键词
药物临床试验
质量控制
管理
clinical drug trial
quality control
management
