The design and implementation of drug clinical trials should follow the relevant requirements of clinical trial management norms and standard operating procedures

minimize the occurrence of deviations and violations in the trial

but it is difficult to avoid deviation from the experimental scheme during the implementation process. This paper introduced the definition and classification of program deviations. It is believed that the common causes are mostly from the subject factors

the researcher factors

and the trial organizer factors. The weight of the deviation scheme will have different effects on the research results. Taking the clinical research on traditional Chinese medicine（ TCM） infertility in polycystic ovary syndrome as an example

the basic situation of the deviation program in the test process was analyzed

and the solution strategy was proposed to provide ideas for improving the quality of TCM clinical trial research.