药物临床试验机构管理质量提升经验总结

Summary of Experiences in Quality Improvement of Drug Clinical Trial Organization Management

药物临床试验机构作为保障人体健康和药物安全的重要环节,应通过定期自查,发现存在的问题,进行相应的改进,确保试验的合规性,保障药物临床试验机构的管理质量。同时应重视设备与设施管理质量提升、强化标准操作规程管理制度、完善人才体系等策略,通过相关管理方法的落实与应用,提高药物临床试验机构的管理质量。本文旨在总结机构需要自查的重点内容,提高机构内涵建设,为其他机构建设提供启发和借鉴。

As an important link in safeguarding human health and drug safety,clinical trial organizations should discover existing problems through regular self-inspection and make corresponding measures to ensure trial compliance and guarantee the management quality of clinical trial organizations.At the same time,more attentions should be paid on the quality of equipment and facilities management,the standard operating procedures management system and the talent systems.The purpose of this paper is to summarize the key contents of self-inspection,improve the internal construction of the organization,and provide inspiration and reference for the construction of other organizations.