Construction and practice of CRC management system based on the whole process of clinical trial projects
10.3760/cma.j.cn113565-113565-20220524-00091
- VernacularTitle:基于临床试验项目全过程的CRC管理体系建设与实践
- Author:
Jian JIN
1
;
Yongfang YUAN
Author Information
1. 上海交通大学医学院附属第九人民医院药物临床试验机构 200011
- Keywords:
Clinical Research Coordinator;
Clinical trial;
Management system
- From:
Chinese Journal of Medical Science Research Management
2022;35(6):476-480
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To introduce the construction and practice of the Clinical Research Coordinator(CRC) management system based on the whole process of the clinical trial project in Ninth People′s Hospital of Shanghai Jiao Tong University School of Medicine.Methods:Constructed CRC management system with hospital features, including the management of admission, examination, training, emergency, and evaluation.Results:CRC management system was put into practice, and investigators, sponsors, and drug clinical trial institutions were highly satisfied with clinical trials using this system.Conclusions:With the gradual formation of CRC industry norms and consensus, the standardized management of CRC can promote the development of China′s pharmaceutical industry.
