体外诊断试剂临床试验质量控制关键点探讨

Analysis of Quality Management of in Vitro Diagnostic Reagent Clinical Trials

体外诊断试剂临床试验是体外诊断试剂研发的重要环节。该文根据《体外诊断试剂临床试验指导原则》及现场检查要点,结合实际工作经验,对体外诊断试剂临床试验过程中关键部分进行总结分析,旨在提高体外诊断试剂临床试验质量管理水平,保证体外诊断试剂临床试验质量。

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.