Abstract:
A clinical research project of high quality cannot be carried out without standard data management and quality control. Data management and quality control of clinical research should be started from the design of the study and performed throughout the whole process of study. The process of data management includes planning, the design of case reporting form, data dictionary and coding specification, construction of the database, data collection and monitoring, data input, data auditing and cleaning, generation of new key variables, medical coding, deidentification, data review and data lock. Strict data management and quality control can improve the integrity and accuracy of clinical research, and further improve the quality of the overall clinical research project.