临床试验项目启动前的质量管理

Clinical trials quality management prior to start- up

项目启动前的充分准备是保障临床试验质量的第一步,本文主要从药物临床试验机构、伦理委员会、临床试验专业、辅助科室、申办方等在临床试验项目启动前的质量控制作用进行分析和探讨。试验相关的各个角色应各司其职,共同努力才能确保试验过程规范,数据真实可靠。

Adequate preparation prior to start-up is the first step to ensure the good quality of clinical trials. The purpose of this article is to explore the quality control role of drug clinical trial agency, ethical committee, clinical trial departments, ancillary departments and sponsor. Each role should fully perform its duties to ensure clinical trial process standard and data reliable.