临床试验机构伦理委员会标准操作规程

Standard operating procedures for ethics committees in cinstitution of linical trial

依据世界卫生组织“生物医学研究审查伦理委员会操作指南”和我国“药品临床试验管理规范” ,以及本机构伦理委员会的实践 ,制订了临床试验机构伦理委员会各项工作的标准操作规程 ,共计八个方面。

According to Operational Guidelines for Ethics Committees That Review Biomedical Research(WHO, 2000), the Good Clinical Practice (SDA), and existing practice, a Standard Operating Procedures (SOP) for Ethics Committees is established in our institution of clinical trials. This SOP involves eight aspects of medical ethic practice.