药物临床试验项目质量缺陷原因分析及改进措施

摘要：目的 分析药物临床试验项目质量存在的缺陷及原因，探讨提高项目质量的改进措施；方法 通过查阅相关文献，并结合工作中的实践经验，分析目前我国临床试验项目存在的质量缺陷和缺陷产生的原因，同时介绍了提高临床试验项目质量根本措施；结果 提高药物临床试验项目质量的措施在于机构具备清晰的组织架构、完善的管理制度、细化的质量指标、规范的药物管理以及CRC的严格管理。结论　提高临床试验项目质量的根本措施在于完善的制度、合格的人员及人员对各项制度的严格执行。

Analysis and prevention of quality defects on drug clinical trials projects

Objective To analysis the causes of quality defects on drug clinical trials projects and introduce the measures to improve the quality drug clinical trials projects.Method This article state the quality defects on drug clinical trials projects according to the relative literature of document and our own experience in recent years,then introduce the method to improve the quality drug clinical trials projects.Results Establishment a rational organization structure,developing the efficient management systems,improvement feasibility of quality index,manage the investigational drug and strengthening management of clinical research coordinator are recommended to improve quality of clinical trial projects.Conclusion The key and basic measure to improve quality of clinical trials is combine qualified researchers with management systems.