浅谈药物临床试验机构资格认定工作的实践与体会

Superficial Discussion on Practice and Experience of Qualification Identification of Drug Clinical Trial Institution

从机构建设、硬件设施、制度建设、人员培训、模拟认证等方面总结我院在机构资格认定工作的经验和体会。介绍我院开展药物临床试验机构资格认定工作的经验,为同行提供借鉴和参考。

The experience and understanding of our hospital in institutional qualification confirmation from the aspects of institution construction,hardware facilities,system construction,personnel training and simulation certification were summarized.The work experience in the qualification of drug clinical trial institutions carried out in our hospital were introduced.