该院药物临床试验机构质量管理现状及存在问题分析

Analysis of Quality Management Status and Existing Issues in the Drug Clinical Trial Institution in our Hospital

分析该院药物临床试验机构质量管理现状及存在问题,分析原因,探求科学有效的质量控制措施以提高临床试验质量。研究者对临床试验的关注度不够,对药物临床试验相关法律法规知识欠缺,部分监查员专业素质低,成为影响药物临床试验质量的主要因素。只有通过良好的内部质控体系建设,提高专业研究者的临床试验素质和技能,才能保证机构药物临床试验的高质量完成。

The status and existing issues of the drug cl in ical trial institution in our hospital were introduced and the causes were analyzed and the scientific and effective quality control measures were explored in order to improve the cl inical trial quality. The researchers pay insufficient attention to the cl inical trials and lack the drug cl inical trial related laws and regu-lations knowledge, and the professional quality of some supervisors is low, and all of them become the main influence fac-tors of drug cl inical trial quality.We should construct a good internal quality control system and improve the cl inical trial quality and skill of professional researchers, only in these ways can we ensure the completion of the high-quality drug cl ini-cal trial in the institution.