我院药物临床试验机构规范化管理探讨

目的:为各医院药物临床试验机构管理提供参考。方法:结合《药物临床试验质量管理规范》(GCP)的指导原则和《赫尔辛基宣言》的精神,从各方面探讨我院药物临床试验机构的规范化管理情况。结果:我院通过完善相关制度、制定科学的质量控制体系、规范试验药物的管理和定期培训等途径,形成了科学有效的管理体制,保证了药物临床试验的质量。结论:药物临床试验机构的规范化管理能在一定程度上保证药物临床试验过程的规范、结果的科学可靠与受试者的权益及安全。

Exploration of Standardized Management of Drug Clinical Trials Institution in Our Hospital

OBJECTIVE： To provide reference for the management of drug clinical trials institution in hospitals. METHODS： With GCP guidelines and the spirit of Helsinki Declaration, standardized management of drug clinical trials institution was dis- cussed from all sides. RESULTS： Scientific and effective management system had been formulated by perfecting relevant system, formulating scientific quality control system, standardizing trial drug administration and regular training, to ensure the quality of drugs clinical trials. CONCLUSIONS： Standardized management of drug clinical trials institution ensures the standardization of drug clinical trials process, scientific and reliable results and the rights and safety of subjects to some extent.