Establishing a comprehensive mechanism for the initiation and review of investigator-initiated trial(ⅡT)plays an important role in ensuring the scientific validity of clinical research and improving research quality.Since 2021,Zhongshan Hospital affiliated to Fudan University had actively explored improvements in the project management of ⅡT.The hospital had established a standardized grading review management process,developed an integrated clinical research management system,established a three-level clinical research training system,built a methodological support platform,and formulated research plan templates,gradually formed a standardized grading project approval review management mode.As of February 2024,the hospital had completed 400 quick reviews and more than 400 expert letter reviews based on the integrated clinical research management system.The efficiency and quality of ⅡT project approval had been improved.At the same time,over 40 academic salons and forums had been held,cultivating a group of young clinical research talents,providing data management training for more than 30 clinical departments,and promoting the improvement of the quality of research protocol.In the future,hospitals should further optimize their information systems,expand the influence of their training systems,enhance the capabilities of their methodological support platforms,and improve the efficiency of the application of clinical research protocol templates,so as to escort the establishment and implementation of high-quality clinical research projects and provide references for other hospitals'ⅡT project management.
关键词
研究者发起的临床研究/立项管理/科学性审查/临床研究方案
Key words
Investigator-initiated trial/Project management/Scientific review/Clinical research protocol
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