Objective To explain the feasibility and significance of establishing quantitative evaluation index and applying it in quality control of clinical study process

taking using quantitative evaluation criteria in clinical research for instance.Methods Quantitative evaluation indexes for quality control of clinical study on Chinese medicine prevention and treatment of chronic gastritis was established

which included key links of clinical research

such as drug management

randomized implementation

data record

compliance

subjects protection

laboratory testing

etc.The indexes were applied for quality evaluation at each step in the process of the project of "Study on transformation and application of techniques and standards of Chinese medicine prevention and treatment of chronic gastritis"

which was one of the Special Research Projects in Chinese Medicine field.Thus quality of the clinical study might be controlled.Results Findings from three times of quality control quantitative evaluation

at the initial

mid-term stages and before conclusion

respectively

showed that the standardized score of "timeliness of research records"was 0.6 at the initial stage.The standardized scores of "data record"and "studying the compliance of medication"were both 0.8 at the mid-term stage.As for evaluation before conclusion

standardization and integrity of the research record were poor.The standardized scores were both 0.8.Total scores of three times of quantitative evaluation were 91.3

94.6 and 96.7 respectively

which showed a gradually increased trend and reflected that the quality of the research seemed good overall.Conclusion Based on identifying the risk influencing research quality

it might be helpful for managing the quality of research projects in time and improving the research quality effectively to establish quantitative evaluation indexes and apply it for quality control in process of clinical research.