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| 研究者发起的临床研究立项质量评估探讨 |
| Quality evaluation of investigator-initiated trials at approving stage |
| 投稿时间：2018-09-11 修订日期：2018-09-11 |
| DOI：10.3760/cma.j.issn.1006-1924.2019.05.001 |
| 中文关键词: 研究者发起的临床研究 质量评估 风险管理 |
| 英文关键词: Bibliometrics SCI research papers Scientific research management |
| 基金项目:上海申康医院发展中心临床管理优化项目(2017SKMR 21) |
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| 摘要点击次数: 783 |
| 中文摘要: |
| 目的 随着研究者发起的临床研究蓬勃发展，国家和地方政府、大学、医疗机构等立项部门对其投入的资源越来越多，通过明确研究立项阶段质量评估的内容与方法 ，提升质量评估的系统性和完整性，确保合理配置资源，提升研究水平，保护受试者权益。方法 本文总结了立项阶段质量评估的内容和开展质量评估的保障因素，探讨了研究者发起的临床研究在立项阶段开展质量评估的一些做法。结果 立项阶段质量评估内容主要包括研究选题、研究方案、研究团队与资质、质量控制计划和风险管理。立项管理部门的组织与重视、评估部门和人员的完善以及信息化支持平台是开展立项质量评估的基本保障。结论 研究者发起的临床研究的立项质量评估是研究启动前的关键质量控制环节，需要充分重视和切实落实。 |
| 英文摘要: |
| Objective With the fast development of Investigator Initiated Trials (IIT), more and more resources from the national and local governments, universities and hospitals were invested. It is important to clarify the content and methodologies of quality evaluation of the IITs at the early approval stage to assure more complete and systematic quality assessment, improve resource allocation, enhance the research ability, as well as the protection of human subject. Methods This article summarized the content and related safeguarding measures of quality assessment during the early stage of project setup. Discussed relative practice and experiences of our center. Results The contents of quality evaluation include research topic, study protocol, research team and qualifications, quality assurance plan and risk management. The organizing work and attention of the research administrative department, qualified departments and experts, as well as information platform are the required safeguarding measures for effective assessment.Conclusions Quality evaluation of IITs at the early approval stage is critical segment of study quality assurance. More attention should be paid to make every effort counts. |
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