我国临床试验协调员管理模式现状及应对措施探讨
Discussion on the current situation and countermeasures of clinical research coordinator management mode in China
鞠蕊 1代荫梅 1阴赪宏1
作者信息
- 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
- 折叠
摘要
目的 梳理临床试验协调员(CRC)的工作职责、分析行业内CRC管理、培训中存在的不足,提出可能的改进方案,为CRC队伍的建设和临床试验质量的提升提供思路.方法 通过文献综述和作者在CRC管理工作中的实践经验,分析CRC工作及管理现状,提出CRC的管理建议.结果 当前我国的CRC行业缺乏统一标准和准入机制,导致国内CRC的基本素质和业务能力良莠不齐.通过加强CRC职业的培养力度、明确CRC职业的发展路径、分级分层培养不同等级和专业的CRC、优化薪酬待遇与绩效考评等措施,一方面可稳定CRC人员队伍,另一方面也能促进临床试验高质量运行.结论 建议国内优秀的医疗机构联合申办方和SMO公司,尽快建立起一套规范、统一的CRC职业准入体系和评价标准,提升CRC的工作能力和水平,助力我国不断增长的临床试验需求.
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 man-agement.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 devel-opment paths,arrange different levels and fields of CRC training,adjust wages and appraisals,and take other suitable meas-ures.Conclusions It is proposed that the top medical organizations in China collaborate with sponsors and site management or-ganizations 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.
关键词
临床试验协调员/临床试验/质量/管理Key words
Clinical research coordinators/Clinical trial/Quality/Management引用本文复制引用
基金项目
北京市卫生健康委北京市研究型病房示范建设项目(BCRW202109)
出版年
2024
NETL
NSTL
万方数据