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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.
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10.3969/j.issn.2095-4344.2013.26.009
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In order to safeguard the legitimate rights and interests of the subjects and the interests of the whole society , a relaxed and harmonious environment was created to ensure the normal medical research , clini-cal research trials which fit in trial of ethical review. The protocol assessment form and ICF assessment form to review are two cornerstones of protecting subjects. A good ICF assessment form is a necessary means to help improve the quality of the Ethics Committee for review .
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To introduce professor YAN De-xin's experience in diffrerentiating and treating Emeda with Heart Involved from qi and flood He thinks that pathogenesis of Emeda with Heart Involved is water overflowing due to yang deficiency,internal retention of blood stasis and turbidity.So this disease can be differentiated from these aspects including the disturbance of the functional activities of the lung,failure to transform body fluid;body fluid transformed by blood stasis,simultaneous disorders of both blood and body fluid;deficiency of pectoral qi,derangement of qi and blood.What's more,he proposes the application of drugs for warming yang and promoting blood circulation is very important.