我院药物临床试验机构资格认定复核工作的实践与体会

Practice and Experience of the Qualification-Review of Drug Clinical Trial Institutes in our Hospital

目的介绍我院药物临床试验机构资格认定复核的经验,为同行提供借鉴参考。方法参照《药物临床试验机构资格认定复核检查标准》,结合我院资格认定复核经验,总结资格认定复核准备重点。结果与结论加强研究人员培训,研究者在试验过程中做到保护受试者权益及安全;项目配备临床研究协调员,对于保证药物临床试验项目质量有很大的促进作用,有助于资格认定复核工作的顺利完成。

OBJECTIVE To introduce the experience of qualification-review of drug clinical trial institutes of our hospital, and provide the reference for other hospitals. METHODS According to the ＂drug clinical trial institutions qualification-review criteria＂ and combining with our qualification experience, we summed up the focus of qualification-review. RESULTS and CONCLUSION In the course of the experiment, strengthening the training of researchers,protecting the interests and safety of subjects and equipping clinical research coordinators participate in drug clinical triMs,will promote the qualify and the completion of the qualification-review work.