Discussion on the construction standards of clinical research center initiated by researchers: A case study of clinical research institute of Shanghai Jiao Tong University School of Medicine
10.3760/cma.j.cn113565-20200415-00127
- VernacularTitle:支持研究者发起的临床研究中心建设标准探讨
- Author:
Tiantian QU
1
;
Tienan FENG
;
Qiang LI
;
Wenwen LV
;
Biyun QIAN
Author Information
1. 上海交通大学医学院临床研究中心 200025
- Keywords:
Investigator Initiated Trial;
Construction of clinical research institute;
Standard
- From:
Chinese Journal of Medical Science Research Management
2021;34(1):77-80
- CountryChina
- Language:Chinese
-
Abstract:
Objective:Investigator Initiated Trials (IIT) play a key role in promoting comprehensively the development and homogeneity of clinical diagnosis and treatment, thus, this article aims to explore a set of recommendations for the construction and management of clinical research institutes that support IIT.Methods:Through the combination of literature review and institutional construction practice cases, based on the experience of domestic and foreign universities and well-functioning medical institutions in building clinical research centers, as well as summarizing the construction cases of the clinical research institute of Shanghai Jiao Tong University School of Medicine, to discuss the construction and management plan of such centers.Results:Propose recommendations for the construction and management standards of clinical research centers that support IIT, covering the principles of center construction, basic settings, organizational structure, functional departments, basic platforms, staffing, document management and institutional evaluation.Conclusions:We hope this study can provide reference to universities and medical institutions for the construction of the clinical research institute.
