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,阐述目前我国药物临床试验项目开展过程中存在的质量缺陷和缺陷产生的原因,进一步介绍提高药物临床试验项目质量的具体方法。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院外临床研究协调员的严格管理。结论合格的研究者严格遵循合理的管理制度并执行方案是提高药物临床试验项目质量的关键。
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.
出处
《安徽医药》
CAS
2016年第10期1966-1969,共4页
Anhui Medical and Pharmaceutical Journal
