Application of PDCA Cycle in Ethics Committee Construction of Clinical Trials
In this study,PDCA cycle method was used to analyze the problems existing in the development and construction of clinical trial ethics committee in our hospital from the aspects of hardware facilities,rules and regulations,standard operating procedures,review training,review process,etc.Intervention measures were formulated and implemented;effectiveness checks and post-processing analysis were carried out;and work plans for improvement in the next stage were proposed.Through PDCA virtuous cycle,the hospital improved the construction of ethics archives,established an independent consultant expert database,and introduced information platform construction.As a result,the ethical review process is more standardized than before,the incidence of non-compliance is reduced,and the delay in submission of progress reports is effectively alleviated.It is concluded that the application of PDCA cycle has played a positive role in promoting the development and standardization of clinical trial ethics committee.
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