The establishment of the Independent Data Monitoring Committee (IDMC) is of great significance to the safety of clinical research subjects and the fairness of data, and is becoming an increasingly common part of clinical trials. At present, the rationality and standardization of the establishment of IDMC, the standardization of implementation, and the supervision of IDMC in clinical trials in China are still facing challenges. This article analyzes and discusses the current situation and challenges of establishing IDMC in clinical trials in China by consulting relevant documents, regulations, guiding principles and data of the drug clinical trial registration and information publicity platform of the National Medical Products Administration’s Drug Evaluation Center (CDE) to understand its background, responsibilities, scope of application and requirements of various regulatory departments. Based on the requirements of relevant laws and regulations, suggestions are put forward to provide reference for the establishment and supervision of IDMC in clinical trials in China.

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