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

Clinical laboratory quality management plays a significant role in good clinical practice

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。

Clinical laboratory quality management plays a significant role in hospital comprehensive quality management and good clinical practice（GCP）construction.The laboratory department should not only provide accurate,reliable and high quality test results to the doctors,but should also be truly recognized by the participants,clinicians,researchers and medicine tests officials through implementation of comprehensive quality management.In daily practice,however,these are not enough.We should communicate effectively with different clinical departments to enhance quality management of laboratory departments.Therefore,it is necessary to bring quality control of laboratory department into GCP quality management system.Meanwhile,they need to collaborate closely with hospital quality management system.Only in this way,healthcare quality and research level of GCP can make a gorgeous progress.