基于JCI理念下的临床试验用药品优化管理的探讨

Discussion on the Optimal Management of Clinical Trial Drugs Based on the Concept of JCI

目的阐述西安国际医学中心医院药物临床试验机构的试验用药品在国际医疗机构认证联合委员会(JCI)理念下的管理,研究在试验药物管理过程中存在的主要问题和管理方法。方法参照《药物临床试验质量管理规范》(GCP)、《药物临床试验数据现场核查要点》,通过与国内外文献的比较,结合本机构在管理中取得的经验,分析在管理方面遇到的主要问题和解决方案。结果与结论本院药物临床试验机构严格遵守《药物临床试验质量管理规范》,建立健全药品管理模式,加强监督管理,对建立规范、精细、高效、统一的管理体系具有重要意义。

OBJECTIVE To describe the management of trial drugs under the concept of JCI in the drug clinical trial institution of our hospital,and to study the main problems and management methods in the process of trial drug management.METHODS By referring to the Good Clinical Practice(GCP)and the key points for on-site verification of drug clinical trial data,comparing with domestic and foreign literatures,and combining with the experience gained in the management of the institution,the main problems and solutions encountered in the management were analyzed.RESULTS&CONCLUSION The drug clinical trial institutions of our hospital strictly abide by the GCP,establish and improve the drug management mode,and strengthen the supervision and management.It is of great significance to establish a standardized,refine,efficient and unified management system.