摘要
目的通过对我院临床试验中人类遗传资源的管理情况进行自查,发现问题、解决问题。从而加强药物临床试验的管理,提高药物临床试验水平。方法针对我院药物临床试验机构在按照科技部办公厅2018年7月发布的《关于开展全国人类遗传资源行政许可管理专项检查有关工作的通知》的要求,开展自查过程中发现的问题进行了分析,并提出解决对策与建议。结果与结论目前,我院临床试验中的人类遗传资源管理仍然存在一些不规范的情况。应完善对研究者的培训、优化质控体系与流程、创建各部门联动共同管理的信息化机制,从而加强我国人类遗传资源的保护、管理和研究利用,这对增强我国生物和医药科技的研发能力都具有重要意义。
Objective To find and solve problems through self-audit of human genetic resources management in clinical trials in our hospital so as to strengthen the management of drug clinical trials and improve the test quality level.Methods According to the Notice on Carrying out the Special Inspection on the Management of Human Genetic Resources in China issued by the General Office of the Ministry of Science and Technology in July 2018,the problems found in the process of self-audit were analyzed,and then some countermeasures and suggestions were put forward.Results and conclusion At present,there are still some irregularities in the management of human genetic resources in clinical trials in our hospital.Therefore,the training of researcher should be improved,the quality control system and process should be optimized,and an information mechanism for the joint management of various departments should be established to strengthen the protection,management and utilization of human genetic resources in China.It is of great significance for China to enhance the research and development of biological and medical science and technology.
作者
王瓅珏
吴明凤
王丹蕾
郭丹杰
张华
王豪
WANG Lijue;WU Mingfeng;WANG Danlei;GUO Danjie;ZHANG Hua;WANG Hao(Science and Research Department,Peking University People's Hospital,Beijing 100044,China)
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2020年第7期657-661,共5页
Journal of Shenyang Pharmaceutical University
基金
北京医药临床研发平台(CRO平台):北京生物医药产业跨越发展工程(G20工程)。
关键词
人类遗传资源
药物临床试验
对策建议
human genetic resources
clinical trials of drugs
countermeasures and suggestions
