中医临床研究质量监查的优化

Optimization of quality monitoring of TCM clinical research

对多中心中医临床研究开展质量监查,是进行质量控制的有效措施。文章从实施监查的若干重要环节入手,阐述了监查员选派优化、监查前准备优化、监查内容优化以及监查反馈优化方法,其中在监查内容优化中详述了研究进度、遵从研究方案、原始资料、药物管理、真实性核实、CRF表格、知情同意、电子数据、实验室理化数据、(严重)不良事件的监查重点,藉此为提高中医临床研究质量监查提供了理论探讨。

Conducting quality monitoring to multi-center clinical research is an effective measure of quality control.This study explored the optimization of some key links of quality monitoring of TCM clinical research,i.e.optimization of CRA appointment,optimization of monitoring preparation,optimization of monitoring items,and optimization of monitoring feedback.For monitoring items,this study emphasized on research progress,protocol compliance,original data conservation,medication management,validity,CRF fill-in,informed consent singing and acquisition,EDC,traceability of lab examination,（severe） adverse event reporting in detail,thus providing the theoretical support for quality monitoring improvement of TCM clinical research.