临床试验伦理审查与质量管理的交互模式探讨∗

摘要

临床试验伦理审查与质量管理的交互式模式由建立科学的信息交互式管理平台、知情同意过程的交互式实现、跟踪审查与质量控制的交互式管理几个方面组成，力求弥补现行临床试验伦理审查与质量管理模式的不足，实现临床试验质量的达标与医学伦理准则的全过程、全方位覆盖。%Interactive mode of ethical review and quality management in clinical trials consists of several parts, which includesconstructing a scientific platform of interactive information management, interactive achievement in the process of informed consent,and interactive management of following review and quality control. It aims to rem-edy the existing defects in the ethical review of clinical trials and quality management system, to guarantee the quality of clinical trials, and to achieve the full coverage of ethical codes in clinical trials.