Abstract: OBJECTIVE To formulate the key points of quality management in each link of drug clinical trials, searching for scientific and effective quality management methods to ensure that the drug clinical trial process is standardized and controllable, and finally improve the quality of drug clinical trials. METHODS Through literature search and combined with clinical practice, starting from program design, project approval, team composition, process management, data management and other aspects, and analyze the key points of quality management before, during and after the drug clinical trials and discuss the methods to solve problems and improve the project quality, then establish the quality assurance mechanism. RESULTS A good job in the quality management of drug clinical trials, should focus on the program review, personnel management, process management, medication management and adverse event management work. The investigators, institutional offices and ethics committees should be start with the details and work together to make the quality management better, such as examine the approve projects strictly, monitor the process timely and ending check strictly. CONCLUSION Drug clinical trials it's the last line of defense for new drugs application for that it inspects the two basic attribute of drug efficacy and safety. Only to do the quality management well and adopt an effective mechanism to avoid mistakes in each link of the test, can effectively ensure the clinical trial process standardized and authenticity, and protect the rights of subjects practically.