摘要
随着研究者发起的临床研究(IIT)数量逐渐增多,亟需加强IIT项目的质量管理。本文从IIT项目管理的资金来源、全过程的组织管理体系、风险把控这三个关键环节进行阐述,力求为IIT项目管理的相关部门提供参考。
With the increasing amount of investigator initiated Trials(IIT)we should pay more attention to the management of IIT.This paper analyzes three key aspects of IIT project management:fund support,whole process quality management and risk control,to provide reference for IIT management by relevant authorities.
作者
季晓慧
朱露莎
孔敏
董铖
林梅
JI Xiaohui;ZHU Lusha;KONG Min;DONG Cheng;LIN Mei(Department of Science and Research,Taizhou People's Hospital,the Fifth Affiliated Hospital of Nantong University,Taizhou 225300)
出处
《药学与临床研究》
2019年第6期478-480,共3页
Pharmaceutical and Clinical Research
关键词
研究者发起的临床研究
重要性
关键环节
Investigator initiated trials(IIT)
Project management
Key links