• 国家药监局综合司 国家卫生健康委办公厅
  • 国家药监局综合司 国家卫生健康委办公厅

Construction and practice of a regional clinical research data integration platform based on standardization theory

Corresponding author: fengtienan, tienan@sjtu.edu.cn
DOI: 10.12201/bmr.202312.00022
Statement: This article is a preprint and has not been peer-reviewed. It reports new research that has yet to be evaluated and so should not be used to guide clinical practice.
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    Abstract: Purpose/Significance Regional clinical research data integration is challenging, which has led to a scarcity of Chinese evidence and Chinese protocol in the global clinical research community. Method/Process This study draws upon standardization theory to propose a data standardization system, taking the integration of multi-center clinical research data as a starting point, to explore the construction and application methods of a regional clinical research data platform. Result/Conclusion The theoretical framework of the regional clinical research data platform has been preliminarily established, leading to a significant improvement in the clinical research capabilities of tertiary hospitals in Shanghai. Through the clinical research data platform integrated with the standardization system, a standardized data collection is formed, enabling the possibility of gathering a large amount of standardized clinical research data. This supports the conduct of high-quality clinical research and facilitates the development of Chinese evidence and Chinese protocol.

    Key words: clinical research data; multi-center clinical research data integration; clinical research data platform; data standardization

    Submit time: 14 December 2023

    Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
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  • ID Submit time Number Download
    1 2023-08-01

    bmr.202312.00022V1

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huangxuequn, fengtienan. Construction and practice of a regional clinical research data integration platform based on standardization theory. 2023. biomedRxiv.202312.00022

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