临床试验用药品信息系统管理专家共识  

Expert consensus on information system management of investigational product(s)

作　　者：蔡君龙 周晶晶 李晓晖 胡永芳 马丽萍[4] 刘巧 王少华 肖晟 朱莉[7] 李海俊[7] 林梅[7] 季晓慧[7] 朱雪琦[8] 王佳庆[9] 王姝 李晶 刁丽 郭珊珊 黄文静 杨海淼[13] 曲芯瑶 邱艳 孙梦琦 王述蓉 布格拉·米吉提 刘春丽[15] 林阳[16] 刘利军 丁倩 刘真[19] 呼君瑜 聂明星 朱露莎[7] 容颖慈[20] 唐蕾[20] 王姣 张翌韦 梁欣[21] 张毅[22] 艾俊波 陈舟 曹文忠 谢朝清 曹彩 黄建英[1] CAI Junlong;ZHOU Jingjing;LI Xiaohui;HU Yongfang;MA Liping;LIU Qiao;WANG Shaohua;XIAOSheng;ZHU Li;LI Haijun;LIN Mei;JI Xiaohui;ZHU Xueqi;WANG Jiaqing;WANG Shu;LI Jing;DIAO Li;GUO Shanshan;HUANG Wenjing;YANG Haimiao;QU Xinyao;QIU Yan;SUN Mengqi;WANG Shurong;BUgela·MIjiti;LIU Chunli;LIN Yang;LIU Lijun;DING Qian;LIU Zhen;HUJunyu;NIE Mingxing;ZHU Lusha;RONG Yingci;TANG Lei;WANG Jiao;ZHANG Yiwei;LIANG Xin;ZHANG Yi;AI Junbo;CHEN Zhou;CAOWenzhong;XIE Chaoqing;CAO Cai;HUANG Jianying(Zhongnan Hospital of Wuhan University,Wuhan 430071,China;Changsha Duxact Biotechnology Co.,Ltd,Changsha 410205,China;Beijing Tsinghua Changgung Hospital,Beijing 102218,China;Peking University Shougang Hospital,Beijing 100144,China;Zhongguancun Jiutai Good Clinical Practice Union,Beijing 100080,China;Beijing Absolute Clinical Data System Co.,Ltd,Beijing 100191,China;Jiangsu Taizhou People's Hospital,Taizhou 225300,China;Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China;Beijing Tiantan Hospital,Capital Medical University,Beijing 100050,China;The First People's Hospital of Jinzhong,Jinzhong 030600,China;Cangzhou People's Hospital,Cangzhou 061000,China;Zhongshan Hospital Fudan University,Shanghai 200032,China;The First Affilated Hospital to Changchun Universty of Chinese Medicine,Changchun 130021,China;The Affilated Hospital of Southwest Medical University,Luzhou 646000,China;The First Affiliated Hospital of Xinjiang Medical University,Urumqi 830054,China;Beijing Anzhen Hospital,Capital Medical University,Beijing 100029,China;Institute of Hematology&Blood Diseases Hospital,Chinese Academy of Medical Science&Peking Union Medical College,Tianjing 300020,China;Beijing Chaldren's Hospital,Capital Medical University,Beijing 100045,China;Beijing Obstetrics and Gynecology Hospital,Capital Medical University,Beijing 100025,China;The First Affilated Hospital,Sun Yat-sen University,Guangzhou 510080,China;Beijing Luhe Hospital,Capital Medical University,Beijing 101149,China;Tianjing Eye Hospital,Tianjin 300020

机构地区：[1]武汉大学中南医院,湖北武汉430071 [2]长沙都正生物科技股份有限公司,湖南长沙410205 [3]北京清华长庚医院,北京102218 [4]北京大学首钢医院,北京100144 [5]中关村玖泰药物临床试验技术创新联盟,北京100080 [6]北京阿贝斯努信息技术有限公司,北京100191 [7]泰州市人民医院,江苏泰州225300 [8]首都医科大学附属北京中医医院,北京100010 [9]首都医科大学附属北京天坛医院,北京100050 [10]晋中市第一人民医院,山西晋中030600 [11]沧州市人民医院,河北沧州061000 [12]复旦大学附属中山医院,上海200032 [13]长春中医药大学附属医院,吉林长春130021 [14]西南医科大学附属医院,四川泸州646000 [15]新疆医科大学第一附属医院,新疆乌鲁木齐830054 [16]首都医科大学附属北京安贞医院,北京100029 [17]中国医学科学院血液病医院,天津300020 [18]首都医科大学附属北京儿童医院,北京100045 [19]首都医科大学附属北京妇产医院,北京100025 [20]中山大学附属第一医院,广东广州510080 [21]首都医科大学附属北京潞河医院,北京101149 [22]天津市眼科医院,天津300020 [23]长沙通诺信息科技有限责任公司,湖南长沙410205 [24]湖南微试云医疗信息有限公司,湖南长沙410205

出　　处：《药物评价研究》2021年第5期917-923,共7页Drug Evaluation Research

基　　金：重大新药创制科技重大专项(2020ZX09201007);国家重点研发计划公共安全风险防控与应急技术装备重点项目(2020YFC0844400)。

摘　　要：主要论述《临床试验用药品信息系统管理专家共识》的起草背景、适用范围,以及试验用药品信息化管理系统的架构、配置、管理要求。从临床试验用药品管理的实际出发,对临床试验用药品的流转进行全程化、标准化、精准化和实时化的管理。促使临床试验用药品信息化管理能够实现试验用药品从申办者运输,研究中心接收、验收、入库、存储、出库、领用发放、用药、回收、返还、退回、销毁、留样(如适用)等全流程在线实时记录管理,提高药品管理规范性,保证数据的及时性、准确性、可靠性和可溯源性。The consensus was mainly discussed the drafting background and the range of application of"Expert consensus on information system management of investigational product(s)",it also stipulates the framework,configuration and management requirements of the management system.Considering the actual management of Investigational Products,the products circulation process was managed in a full,standardized,precise and real-time manner.Promoting the information management of Investigational Products could realize the online real-time record management in the whole process,such as transporting,receiving,checking,warehousing,storage,delivery,distribution,administration,recovery,restore,return,destruction,retention(if applicable).The Consensus is committed to improving the standardization of Investigational Products management and ensuring the timeliness,accuracy,reliability and traceability of data.

关 键 词：试验用药品 信息化 管理 

分 类 号：R954[医药卫生—药学]