[摘要] 目的 回顾和总结药物临床试验过程中的常见问题，为我院后期临床试验项目管理积累经验。 方法 对我院已结题的27项药物临床试验项目进行项目核查，发现临床试验中常见问题后，对问题进行分类，并针对各类问题提出相应对策。 结果 我院药物临床试验常见问题主要集中在伦理审查、知情同意、方案实施、数据记录、药物管理和生物样本管理等方面。 结论 加强药物临床试验过程管理是提高药物临床试验质量的关键。

    [关键词] 药物临床试验；项目核查；过程管理；试验质量

    [中图分类号] R95 [文献标识码] C [文章编号] 1673-9701(2017)08-0146-03

    [Abstract] Objective To review and summarize the common problems in the course of drug clinical trial， and to accumulate experience for the late clinical trial project management in our hospital. Methods Project verification was carried out on 27 drug clinical trials which had been finished in our hospital. After the common problems in clinical trials were found ......