临床试验数据采集与报告文件设计制作的技术规程

Technical procedure for design and development of clinical trial data collecting and reporting documents

临床试验数据采集与报告文件的设计和制作对保证试验数据的质量与完整性至关重要。参照临床试验数据管理规范 (GCP)并结合具体实践经验制订本规程。设计规程包括与方案设计同步、文件格式、问题和提示、冗余数据、数据记录指南、标准化、版本管理与培训 ;印制规程包括审批、印制说明书以及厂商选择。

The quality and integrity of the clinical trial data rely importantly on the design and compilation of report documents and the collection of trial data. Therefore,based on practical experiences and with reference to the Good Clinical Data Management,we develop this technical procedure,including designing and printing procedures.