摘要
借鉴风险管理的理论,结合本中心药物临床试验风险管理的应用现状,分析论述如何对临床试验日常管理活动进行风险识别、评估、控制和效果评价,提出药物临床试验机构如何有效进行风险控制的多项建议。
By reference of risk management theory, combined with our center＇s current application status of drug clinical trial risk management, this essay analyzes and discusses how to identify, assess, control and evaluate the risks during daily management activities of clinical trials. It also proposes various recommendations for drug clinical trial institutions on how to conduct risk control effectively.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2011年第10期797-800,共4页
Chinese Journal of New Drugs and Clinical Remedies
关键词
临床试验
危险处理
组织机构
clinical trials
risk management
organizations
