OBJECTIVE To identify the risk points faced during the conduct of clinical trials in the department of rheumatology and immunology based on the clinical trial process, and to provide a reference for the future risk control work of conducting drug clinical trials in the department of rheumatology and immunology.

METHODS Quality control reports, audit reports, supervision reports, etc. were collected to summarise 124 specific risk points of clinical trials in the Department of Rheumatology and Immunology. The probability of occurrence and the degree of influence of each risk point were evaluated by assigning values using an expert evaluation form.

RESULTS A three-level rheumatology clinical trial risk index system was set up to summarise 124 risk points. The top 10 items were screened as key risk points, data recording and reporting and management system/standard operating procedure were the two parts with the highest probability of risk and the highest degree of influence.

CONCLUSION This study takes clinical trials in the department of rheumatology and immunology as the research object, constructs the risk index system, identifies the key risk points by combining the opinions of industry experts, and at the same time, the revision of standard operating procedure is the main risk management measure, which is of certain practical reference value for the improvement of the quality control of clinical trials in the department of rheumatology and immunology.