Discussion on the current situation and countermeasures of clinical research coordinator management mode in China
10.3760/cma.j.cn113565-20230818-00045
- VernacularTitle:我国临床试验协调员管理模式现状及应对措施探讨
- Author:
Rui JU
1
;
Yinmei DAI
;
Chenghong YIN
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，北京 100026
- Keywords:
Clinical research coordinators;
Clinical trial;
Quality;
Management
- From:
Chinese Journal of Medical Science Research Management
2024;37(4):344-350
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To make clear the duties of the clinical research coordinators (CRC) and evaluate any inadequacies in their management and training in the industry, ideas for ameliorating the construction of the CRC team and the promotion of clinical trial quality should be suggested.Methods:Drawing from the author′s experience in CRC management and a literature review, this paper assessed the current state of CRC work and management, and provides advice on how to improve CRC management.Results:In China, the CRC domain lacked a unified standard and access mechanism, leading to inconsistent levels of basic quality and business ability among CRC offerings within the sector.In order to maintain a steady CRC personnel team and promote the quality of clinical trials, it was essential to improve the training of CRC professionals, determine their career development paths, arrange different levels and fields of CRC training, adjust wages and appraisals, and take other suitable measures.Conclusions:It is proposed that the top medical organizations in China collaborate with sponsors and site management organizations to create a standardized and unified CRC occupational admission system and assessment criteria, in order to enhance the capacity and standard of CRC and addressing China′s increasing demand for clinical trials.
