临床研究协调员现状调查与分析

Q4 Health Professions
Yung-Hao Feng, L. Rao, J. Qiao
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引用次数: 0

摘要

目的:了解复旦大学上海肿瘤中心临床研究协调员(CRCs)的现状,以优化现有的管理模式,提高药物临床试验的质量。方法:采用自制问卷对我院104名中心进行调查,问卷内容包括中心的专业背景、面临的问题以及对当前管理模式的意见或建议。最后,对所得结果进行描述性统计分析。结果与结论:该院CRCs大部分具有相关医学本科以上学历,80%以上的CRCs工作年限在3年以下,不到50%的CRCs在上岗前曾独立从事过临床试验。绝大多数人对自己的职业有热爱和成就感,但只有20%的人有回家的感觉和认同。工作压力大、对薪酬不满意的情绪普遍存在。在工作中,偶尔会出现受试者与静脉药物调配中心(PIVAS)、中心配合不佳的情况。对医院目前的中心管理模式提出了一系列建议。应采取设置CRCs准入门槛、提高薪酬、丰富培训内容、改革PIVAS工作制度、增强临床研究人员的责任感、定期举行非正式讨论等措施,从专业和长期稳定两方面加强CRCs队伍建设。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Investigation and analysis of the status of clinical research coordinators
Objective: To investigate the current status of clinical research coordinators(CRCs) in Fudan University Shanghai Cancer Center,so as to optimize the current management mode and improve the quality of drug clinical trials.Methods: A survey was made among 104 CRCs in the hospital by using a self-made questionnaire,which included professional background,problems facing CRCs and their opinions or suggestions concerning the current management mode.Finally,the study made a descriptive statistical analysis of the obtained results.Results and Conclusion: Most of the CRCs in the hospital had an educational background of above undergraduate course in related medical science,over 80% of them had service years of less than 3 years,and less than 50% of them used to undertake clinical trials independently before they took up their posts in the hospital.The majority of the CRCs had a love for their profession and a sense of accomplishment,but only 20% of them had a sense of home-coming and approval.The feelings of heavy workload and dissatisfaction with salary widely existed among CRCs.Poor cooperation between subjects and pharmacy intravenous admixture service(PIVAS) and CRCs occasionally occurred in work.CRCs put forward a series of suggestions on the current CRCs management mode in the hospital.Such measures as setting up CRCs access threshold,raising salary,enriching training contents,reforming the work system of PIVAS,enhancing the sense of responsibility of clinical researchers,and holding regular informal discussions should be taken to intensify the construction of the CRCs team both professionally and from the aspect of team stability in the long run.
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来源期刊
药学服务与研究
药学服务与研究 Health Professions-Pharmacy
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