体外诊断试剂临床试验的特点及管理对策探讨

doi:10.3969/j.issn.1674-1633.2017.10.039

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摘要本文就目前体外诊断试剂临床试验的特点：产品项目繁杂，样本例数多、质控难度大，样本及体外诊断试剂管理要求高，试验过程及试验人员的要求高等问题进行分析。就如何确保试验结果的真实性、科学性和可靠性进行了体系建设的探讨。

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	张晓燕
	王学军
	朱丹丹

关键词 ：体外诊断试剂, 临床试验, 冷链管理, 质量控制

Abstract：In this paper, the characteristics of the in vitro diagnostic reagents clinical trials were analyzed, including the multifarious product, large-scale sample, big difficulty in quality control, the higher management requirement of samples and in vitro diagnostic reagents. The process of clinical trial and the skill of personnel should also be taken into consideration. Moreover, the paper also discussed relevant solutions of system construction which ensured the authenticity, scientific, reliability of test results.

Key words： in vitro diagnostic reagent clinical trials cold chain management quality control

收稿日期: 2016-08-09

R197.39

作者简介:

引用本文:

张晓燕，王学军，朱丹丹. 体外诊断试剂临床试验的特点及管理对策探讨[J]. 中国医疗设备, 2017, 32(10): 144-146.
ZHANG Xiaoyan, WANG Xuejun, ZHU Dandan. Discussion on the Characteristics and Management Strategies of the in Vitro Diagnostic Reagents Clinical Trials. China Medical Devices, 2017, 32(10): 144-146.

链接本文:

http://cs.china-cmd.org/zgylsb/CN/10.3969/j.issn.1674-1633.2017.10.039 或 http://cs.china-cmd.org/zgylsb/CN/Y2017/V32/I10/144

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