摘要
目的:探讨临床试验用药品的管理模式。方法:按照《药物临床试验质量管理规范》(GCP)的规定,并结合我院实际情况制订试验用药品管理机制。结果与结论:初步建立了药物临床试验机构办公室负责试验用药品的验收、回收、督导、培训,临床专业组负责试验用药品的保管、分发和使用的试验用药品管理模式,保证试验用药品"专人、专柜、专锁"管理;同时将试验用药品的管理纳入药物临床试验质量控制体系。但建立既符合法规要求又能适应本院实际情况的、较为完善的试验用药品管理模式需要长期努力、多方协调才能达成。
OBJECTIVE ： To discuss the management model of clinical trial drugs in hospitals. METHODS ： Based on the related regulations of Good Clinical Practice （GCP） and the actual situation of our hospital, the management mechanism of trial drugs had been developed. RESULTS ＆ CONCLUSIONS： Trial drug management model has been established initially, including the ofrice of drug clinical trial institution responsible for the acceptance, recovery, supervision and training of clinical trials drug; clinical section responsible for storage, distribution and use of clinical trials drugs. The clinical trials drug management of ＂special personal, special counter and special lock＂ can be ensured. The management of trial drugs has been included in quality management system of drug clinical trials. More perfect management model of clinical trial drugs, which in line with the rules, regulation and the situation of the hospital, can be achieved by long-tem effort and multilateral coordination.
出处
《中国药房》
CAS
CSCD
2014年第5期408-410,共3页
China Pharmacy
关键词
临床试验用药品
医院
管理模式
质量控制
Clinical trial drug
Hospital
Management model
Quality control
