title: [Construction and implementation of quality control index for clinical safety of Chinese medicine injection].
abstract: In order to ensure the authenticity and accuracy of traditional Chinese medicine injection safety monitoring data, Chinese medicine injection safety monitoring quality control indicators, including the monitoring center, monitoring personnel, hardware conditions, monitoring progress and the number of patients into the group, original documents and archives management, electronic data, adverse events, quality management were constructed. Its application in the creation of major new drugs technology major projects, 10 kinds of traditional Chinese medicine injections clinical safety monitoring quality control work, found the missing case surveillance, not reported adverse events, only reported adverse reactions, electronic data reporting lag, lack of level of efforts to control the problem, and corrected, the traditional Chinese medicine injection safety monitoring of quality control and quality assurance, and subsequent Chinese medicine safety monitoring quality control to provide the reference.
authors.forename: Jun-jie
authors.initials: JJ
authors.lastname: Jiang
authors.forename: Yan-ming
authors.initials: YM
authors.lastname: Xie
mesh_terms: D006801:Humans; D007267:Injections; D008516:Medicine, Chinese Traditional / Q000009:adverse effects / Q000592:standards*; D011786:Quality Control