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    Clinical trial is an important step of in vitro diagnostic reagents research and development. Based on the Guiding Principles and the key points of inspect on the spot, combined with the actual work experience, the article focuses on the prominent problems in the whole process of in vitro diagnostic reagent clinical trials. It is helpful to improve the level of hospital drug clinical trial centre and the quality of in vitro diagnostic reagent clinical trials by analyzing the issues.

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    Man Lyu, Dunyao Bai, Luan Chen, Jieli Luo. Analysis of Quality Management of in Vitro Diagnostic Reagent Clinical Trials]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation. 2020 Oct 08;44(5):436-438

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    PMID: 33047569

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