Optimization of quality monitoring of TCM clinical research
- VernacularTitle:中医临床研究质量监查的优化
- Author:
Rui LI
;
Weiliang WENG
;
Qiuyan LI
;
Yuanxiang TIAN
- Publication Type:Journal Article
- Keywords:
TCM clinical research;
Quality monitoring;
Optimization
- From:
China Journal of Traditional Chinese Medicine and Pharmacy
2006;0(09):-
- CountryChina
- Language:Chinese
-
Abstract:
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.
