中华医学科研管理杂志2024,Vol.37Issue(6) :497-501.DOI:10.3760/cma.j.cn113565-20240124-00029

口腔专科医院临床试验管理模式建设的探讨

Discussion on the construction of clinical trial management model in dental specialty hospitals

卢子倩 杜灿 韩祺 李盛 巨佳 李佳
中华医学科研管理杂志2024,Vol.37Issue(6) :497-501.DOI:10.3760/cma.j.cn113565-20240124-00029

口腔专科医院临床试验管理模式建设的探讨

Discussion on the construction of clinical trial management model in dental specialty hospitals

卢子倩 1杜灿 1韩祺 1李盛 2巨佳 3李佳1
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作者信息

  • 1. 四川大学华西口腔医院,国家口腔疾病临床医学研究中心,成都 610041
  • 2. 南京医科大学附属口腔医院,南京 210004
  • 3. 中国人民解放军空军军医大学第三附属医院,西安 710032
  • 折叠

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人手加强管理,确保临床试验有效运行,并进一步提升临床试验质量.

Abstract

Objective This study aims to analyze the current status of clinical trial management in dental specialized hos-pitals under the record-filing system for clinical trial institutions,and to propose targeted optimization measures,aiming to im-prove management level and provide reference for the establishment of a clinical trial management model with characteristics of dental specialized hospitals.Methods A survey was conducted on multiple dental specialized hospitals in China to understand the existing problems and excellent management experiences in clinical trial management.Results In the current clinical trial management of dental specialized hospitals,there were still problems such as unclear positioning of internal management de-partments,insufficient number of full-time personnel,and weak awareness of Good Clinical Practice(GCP)among research-ers.Conclusions Dental specialized hospitals can strengthen management by clarifying the positioning of clinical trial manage-ment departments,implementing a project responsibility system for full-time personnel,improving the construction of manage-ment systems,and strengthening researcher training,so as to ensure the effective operation of clinical trials and further im-prove their quality.

关键词

口腔专科医院/临床试验/管理/模式/试验质量

Key words

Dental hospital/Clinical trial/Management/Model/Trial quality

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出版年

2024
中华医学科研管理杂志
中华医学会

中华医学科研管理杂志

CSTPCD
影响因子:0.515
ISSN:1006-1924
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