研究者发起临床研究项目信息化管理平台的设计与实践经验  

Design and practical experience of information management platform for investigator initiated trials

作　　者：吴倩 胡俊 王文辉[3] WU Qian;HU Jun;WANG Wen-hui(Clinical Trials Center,The Sixth Affiliated Hospital,Sun Yat-sen University,Guangzhou 510655,China;Guangdong Institute of Gastroenterology,Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases,Supported by National Key Clinical Discipline,Guangzhou 510655,China;Network Information Center,The Sixth Affiliated Hospital,Sun Yat-sen University,Guangzhou 510655,China)

机构地区：[1]中山大学附属第六医院临床研究中心,广州510655 [2]广东省胃肠病学研究所广东省结直肠盆底疾病研究重点实验室,广州510655 [3]中山大学附属第六医院信息科,广州510655

出　　处：《中国新药杂志》2019年第24期2987-2991,共5页Chinese Journal of New Drugs

基　　金：广东省科技计划资助项目(2015B010129008)

摘　　要：鉴于国内目前对研究者发起的临床研究(investigator initiated trials,IIT)管理可遵循的法规不多,相较新药类临床研究,此类管理难免流于形式,针对其不够规范、系统的现状,我院参照新药临床试验的管理规范,设计建设了临床研究信息化管理平台,系统涵盖研究者发起的临床研究全流程所有参与角色,线上联络及时反馈,数据留存在服务器,可随时随地调取,在立项、启动、质控、年审、结题等重点环节多角色协同办公,落实对研究者发起的临床研究的规范化、专业化、中心化的全流程管理,使用技术手段来节约人力、约束科研、促进科研。通过平台使用,研究质量得到保障的同时,研究者和管理者的工作也更加高效,为促进我院研究者发起的临床研究未来更蓬勃的发展创造了条件。Currently,there are few regulations that can be followed in the management of Investigator Initiated Trials(IIT)in China.Compared with the new drug clinical research,such management is inevitably lacking in standardization and systematization.Thus,with reference to the management regulations of clinical trials of new drugs,our hospital designed and constructed a clinical research information management platform.This system covers all the participating roles of the IIT process.The online contact is instant,and the data can be reserved in the server,and retrieved at anytime and anywhere.Key functions,such as project launching and initiation,quality control,annual review,and project completion,work together to implement the standardization,specialization,and centralized process management of IIT.Through the use of this platform,the quality of research is guaranteed,and the work of researchers and managers is more efficient in the meantime.This system creates conditions for promoting more vigorous development of IIT in the future.

关 键 词：研究者发起的临床研究 信息化 管理 

分 类 号：R969.4[医药卫生—药理学]