Objectives To analyze the clinical compliance and the influencing factors of patients with chronic hepatitis B in the clinical research of traditional Chinese medicine（ TCM）. Methods The participants from 13 clinical research centers nationwide who participated in the National TCM Clinical Research Base（ Hubei） from June2012 to August 2016 were selected to retrospectively analyze the clinical compliance of the subjects. By using the"arrival rate"method

the assessment of subject compliance was conducted. Logistic regression was used to analyze the influencing factors of clinical compliance. Results A total of 620 cases were included in the study. After follow-up for 48 weeks

59 cases（ 9. 5%） were lost. 561 participants（ 90. 5%） completed all visits

including 356 participants（ 63. 5%） that visited on time and completed relevant examinations and tests

and 205 participants（ 36. 5%） that visited over the deadline or did not complete the related clinical data as required. The compliance of subjects in different regions decreased gradually in 4

8

12

24

36

and 48 weeks（ P < 0. 01）. Univariate analysis showed statistical difference（ P < 0. 05） in 6 clinical compliance differences including family history

clinical research coordinator（ CRC）

chronic liver disease quality of life questionnaire（ CLDQ）

Short Form 36 Health Survey Questionnaire（ SF-36）

health changes

and TCM syndrome scores. Regression analysis showed that the impact of CRC and SF-36 scores on clinical compliance was prominent. CRC was positively correlated with clinical compliance（ P < 0. 05）

and SF-36 scores was negatively correlated with clinical compliance（ P < 0. 05）. At the same time

the results showed that the patient’s family history

CLDQ

health changes

TCM syndrome scores

etc. did not show a correlation with compliance. Conclusion The on-time visit rate gradually decreases with the extension of follow-up time. CRC and SF-36 scores are important influencing factors of clinical compliance.