摘要
目的分析临床试验机构备案制下,口腔专科医院临床试验管理现状,并针对性提出优化措施,以期提升管理水平,为建设具有口腔专科医院特色的临床试验管理模式提供参考依据。方法对国内多家口腔专科医院进行案例分析,了解目前在临床试验管理方面存在的问题以及优秀管理经验。结果目前在口腔专科医院临床试验管理上,尚存在医院内管理部门定位不清、专职人员较少和研究者GCP意识淡薄等问题。结论口腔专科医院可从明确临床试验管理部门的定位、实施专职人员项目负责制、完善管理体系的建设及加强研究者培训等方面入手加强管理,确保临床试验有效运行,并进一步提升临床试验质量。
ObjectiveThis study aims to analyze the current status of clinical trial management in dental specialized hospitals under the record-filing system for clinical trial institutions,and to propose targeted optimization measures,aiming to improve management level and provide reference for the establishment of a clinical trial management model with characteristics of dental specialized hospitals.MethodsA survey was conducted on multiple dental specialized hospitals in China to understand the existing problems and excellent management experiences in clinical trial management.ResultsIn the current clinical trial management of dental specialized hospitals,there were still problems such as unclear positioning of internal management departments,insufficient number of full-time personnel,and weak awareness of Good Clinical Practice(GCP)among researchers.ConclusionsDental specialized hospitals can strengthen management by clarifying the positioning of clinical trial management departments,implementing a project responsibility system for full-time personnel,improving the construction of management systems,and strengthening researcher training,so as to ensure the effective operation of clinical trials and further improve their quality.
作者
卢子倩
杜灿
韩祺
李盛
巨佳
李佳
Lu Ziqian;Du Can;Han Qi;Li Sheng;Ju Jia;Li Jia(West China Hospital of Stomatology,Sichuan University,National Clinical Research Center for Oral Diseases,Chengdu 610041,China;Stomatological college of Nanjing Medical University,Nanjing 210004,China;School of Stomatology of Air Force Medical University,Xi′an 710032,China)
出处
《中华医学科研管理杂志》
2024年第6期497-501,共5页
Chinese Journal of Medical Science Research Management
基金
四川省卫健委临床研究专项(23LCYJ052)。
