This article summarized the data characteristics of traditional Chinese medicine（TCM） case records

analyzed the related research dilemma

and discussed the method of forming TCM cases data into real-world evidence（RWE） based on real-world studies（RWS）. It was found that the content of the TCM case records has the characte-ristics of authenticity

regularity

individualization

and selective differences; and the form was dynamic and complex. The problems of current researches on TCM case records were mainly from the limitation of its data characteristics

insufficient existing research methods

and poor quality of medical records. Considering the characteristics and problems mentioned about TCM case records and referring to the RWS methods

it was put forward to establish a TCM medical records quality evaluation system

to take individual cases as evidence for the evaluation of TCM

to take individual medical visit as a unit to evaluate TCM

and to construct a TCM clinical evidence grading system

thereby providing new ideas and methods for the evaluation of the effectiveness and safety of TCM.