浅谈临床实验室质量控制在药物临床试验工作中的重要性

发布时间：2019-03-05 09:07

【摘要】：临床实验室质量管理是医院全面质量管理的重要组成部分,同时也是医院药物临床试验管理规范(GCP)建设的重要内容。检验科实行全面的质量管理是为了向临床提供精准的、可信赖的、高品质的检验结果,并得到药物临床试验受试者、临床医师或研究者和药物临床试验机构办公室的信赖与认可。但是在实际工作中,仅通过检验科实行全面的质量管理还不够,同时还需要与各个临床科室进行多种形式的有效沟通,以此来实现检验科质量管理的提升。所以把检验科质量控制增加到GCP质量管理体系是非常有必要的,与此同时还要和医院质量管理体系有机结合才能使医院的医疗质量得到了显著的提升,GCP的研究水平也就得到了相应的提升。
[Abstract]:Clinical laboratory quality management is an important part of hospital total quality management, and it is also an important content of hospital drug clinical trial management standard (GCP) construction. The purpose of comprehensive quality management in the laboratory is to provide accurate, reliable and high-quality testing results to the clinical trials of drugs. Trust and recognition by clinicians or researchers and the Office of Drug Clinical Trials. However, in practice, it is not enough to carry out comprehensive quality management through the laboratory. At the same time, it is necessary to communicate effectively with various clinical departments in order to improve the quality management of the laboratory. Therefore, it is very necessary to increase the quality control of the laboratory to the GCP quality management system. At the same time, it is necessary to combine with the hospital quality management system to make the hospital's medical quality significantly improve. The research level of GCP has been improved accordingly.
【作者单位】：武汉大学中南医院药物临床试验机构办公室;武汉大学中南医院检验科;
【基金】：湖北省自然科学基金重点项目(编号:2013CFA048) 中央高校基本科研业务费专项资金(编号:2042014kf0108)
【分类号】：R95

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