Study on TCM Clinical Research Primary Quality Control and Management
10.3969/j.issn.1005-5304.2016.11.001
- VernacularTitle:中医临床研究一级质量控制管理研究
- Author:
Miaomiao CHENG
;
Weiliang WENG
;
Rui LI
;
Fang LU
- Publication Type:Journal Article
- Keywords:
TCM;
clinical experiment;
quality control;
primary quality control
- From:
Chinese Journal of Information on Traditional Chinese Medicine
2016;23(11):1-3,4
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo investigate and analyze the current primary quality management situation in TCM clinical studies.Methods One sub-center unit from 39 projects of “Prevention and Treatment of Difficult and Complicated Disease of TCM” plan of the“11th Five-year National Key Technology R&D Program” was chosen. Executive condition of the primary quality control of each unit was under field investigation, and quality control quantitative evaluation indexes were used to conduct quantitative evaluation.Results Results were shown as the forms of statistical description and radar map. The average and median scores of primary quality management were 5.05 and 5.2, respectively. The best and preferable proportions of 39 units were 25.64% and 28.21%. Other 46.15% of these units performed poor. The problem mainly manifested on insufficient frequency and bad normalization of primary quality management, such as comprehensiveness and integrity of inspection contents, cases, problem recordings and problems timely feedback.ConclusionAlthough the primary quality management is widely conducted in TCM clinical studies, there are still some problems to be settled and improved.
