研究者发起的临床研究实施流程探讨

Discussion of the process of conducting an investigator-initiated research

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.