如何制定临床试验数据与安全监察委员会章程

How to develop charter for clinical trial data and safety monitoring board

我国的随机对照临床试验中越来越多设立数据和安全监察委员会(DSMB),但在组织和操作过程中缺少具体的法规指导和支持。本文结合国际指南、文献、实践经验,设计数据和安全监察委员会章程,内容包括:简介、专家组成、责职、会议纪要、递交给DSMB的报告、DSMB建议及文件存档等,并提供模板文件供业界参考。

The data and safety monitoring board （DSMB） from randomized controlled trials （RCTs） is becoming more common in our country, but with little guidance on how they should operate. We develop a charter template for DSMB in clinical trial on the basis of international guidelines, literature and our experience for reference. The content includes introduction, composition, responsibility, minutes of meeting, communication reports to DSMB, recommendations of DSMB, document retention and so on.