Project management of clinical research initiated by investigators in medical institutions
10.3760/cma.j.cn113565-20200225-00058
- VernacularTitle:医疗机构内研究者发起临床研究的项目管理思考
- Author:
Zhen LIU
1
;
Chunshui WANG
;
Yinmei DAI
;
Junyu HU
Author Information
1. 首都医科大学附属北京妇产医院药物临床试验机构办公室 100026
- From:
Chinese Journal of Medical Science Research Management
2020;33(4):260-263
- CountryChina
- Language:Chinese
-
Abstract:
Objective:This paper aimed to explore the problems and solutions in the management of Investigator-Initiated Trail (IIT) in medical institutions, to provide suggestions particularly in the absence of relevant high-level policy support.Methods:By combining literature review with working practice experiences, this paper analyzed the current situation of IIT’s management and the rationale, put forward suggestions.Results:IIT related problems identified including as the responsible entities of the management, research topics selection, protocol design, continuity, research team construction, ethical review and the cultivation of research management personnel. The centralized management will help the standardized management of such projects, the training of investigators and team building, the review awareness strengthening of the ethics committee, improvement of management ability.Conclusions:IIT plays an important role in promoting the development of medical scientific research. Medical institutions should integrate resources, provide platforms, train investigators assure the quality of IITs.
