摘要
研究者发起的临床研究(investigator-initiated research,IIR)日益增多,但目前国内对IIR的认知和管理均处于起步阶段,尚缺乏具体、可操作性强的实施流程指导。笔者结合自身实践经验、既往文献报道和目前政策规定,以前瞻性IIR为例,将IIR的实施流程总结为14个步骤:研究立项、伦理审查、研究注册、研究备案、病例报告表设计、数据库建立、标准操作规程制作、研究者培训、知情同意、数据采集、数据录入、数据核查、数据锁定和数据归档。
The number of investigator initiated research(IIR)is increasing.But the recognition and management of IIR in China is still in its infancy,and there is a lack of specific and operable guidance for the implementation process.Based on our practical experiences,previous literature reports,and current policy regulations,the authors took prospective IIR as an example to summarize the implementation process of IIR into 14 steps,which are as the following:study initiation,ethical review,study registration,study filing,case report form design,database establishment,standard operating procedure making,investigator training,informed consent,data collection,data entry,data verification,data locking and data archiving.
作者
戴维
魏星
王雅琴
刘杨珺
廖佳
谢少华
胡彬
余鸿凡
蒲杨
徐玮
赵宇倩
刘芳
刘晓琴
庄翔
沈碧玉
万绍平
李强
石丘玲
DAI Wei;WEI Xing;WANG Yaqin;LIU Yangjun;LIAO Jia;XIE Shaohua;HU Bin;YU Hongfan;PU Yang;XU Wei;ZHAO Yuqian;LIU Fang;LIU Xiaoqin;ZHUANG Xiang;SHEN Biyu;WAN Shaoping;LI Qiang;SHI Qiuling(Department of Thoracic Surgery,Sichuan Cancer Hospital,School of Medicine,University of Electronic Science and Technology of China,Chengdu,610041,P.R.China;Department of Medical Epidemiology and Biostatistics,Karolinska Institute,Stockholm,17177,Sweden;School of Public Health,Chongqing Medical University,Chongqing,400016,P.R.China;Department of Science and Technology,Sichuan Cancer Hospital,School of Medicine,University of Electronic Science and Technology of China,Chengdu,610041,P.R.China;Department of Chinese and Western Medicine,Sichuan Cancer Hospital,School of Medicine,University of Electronic Science and Technology of China,Chengdu,610041,P.R.China;Department of Nursing,Shanghai Children's Medical Center,School of Medicine,Shanghai Jiao Tong University,Shanghai,200127,P.R.China)
出处
《中国胸心血管外科临床杂志》
CSCD
北大核心
2023年第2期299-304,共6页
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery
基金
国家重点研发计划(2020YFB0408400)
四川省科技项目(2019YFG0517)
成都市科技项目(2019-YF09-00234-SN
2021-YF05-02138-SN)
四川省临床重点专科建设项目。
关键词
研究者发起的临床研究
实施流程
数据库
标准操作规程
数据管理
Investigator-initiated research
implementation process
database
standard operating procedure
data management