One of the controversial issues that fail to develop into consensus over the years in clinical research is how to evaluate the traditional Chinese medicine（ TCM） therapeutic effect. The limitations of applying evidencebased medicine and clinical epidemiology methods to evaluate the effect of TCM treatment based on syndrome differentiation have been increasingly realized. Therefore

individualized evaluation that accords with characteristics of TCM diagnosis and treatment has been widely accepted. However

owing to the lack of suitable evaluation model and method

the design and implementation of such evaluation and comprehensive and objective evaluation on the clinical efficacy of TCM are difficult. By considering the disadvantages of standardization evaluation on TCM treatment and the epochal theories and methods on big data and real world evidence

thhis paper analyzes the core in implementing the individualized evaluation on TCM treatment effect

such as the individualized clinical information collection

individualized intervention

and individualized therapeutic effect evaluation mode and method.