Practical exploration of clinical research unit platform construction and management mode based on research-oriented hospitals: The case study of a tertiary hospital in Shanghai

Objective To summarize the practical experiences of Clinical Research Unit (CRU) platform established by Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine, provide reference for domestic institutions that have prepared or to prepare to establish CRU platform. Methods Oriented by demand, this platform has set up six modules including project management module, methodology support module, data management module, quality risk management module, project transformation module and training and international exchange module. Besides, it also establishes and improves the corresponding module system, quality assurance, technical support and information data platform system. Results With this platform, the enthusiasm of departments to carry out clinical research has been continuously enhanced, the talent pool of clinical research has been expanded; the awareness of clinical research cooperation has been improved and the international cooperation fields have been further extended; the number of clinical research projects and funding have increased rapidly. Conclusions CRU Platform in Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine provides all-dimensional technical support and whole-process informatization management to improve clinical research quality and efficiency. While learning from the advanced international concepts, we still need to explore and improve the platform construction and management mode in line with general research-oriented hospitals in China, further to enhance the academic research internationally. Key words: Clinical Research Unit; Platform construction; Management mode