Objective This study aims to explore a new model of quality control management for drug clinical trials in the hematology department to ensure the quality of clinical trials of new drugs for hematologic disorders.Methods Given the com-plexity and severity of hematologic diseases and various issues currently existing in clinical study,the hematology department of First Affiliated Hospital of Soochow University established a quality control management model based on the characteristics of hematology and department management system.Results The department set up a working group to build a quality control management system for the hematology specialty group through a series of measures,including establishing a quality control group,setting up quality control checkpoints,standardizing the quality control process,formulating quality control forms,etc.Conclusions Establishing an effective quality control management model could help improve the implementation level of re-searchers and the quality of clinical trials.
关键词
药物临床试验/质量控制/血液专业组
Key words
Drug clinical trials/Quality control/Department of hematology
维普
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