关键词: 临床试验数据监测委员会, 临床试验, 不育, 女（雌）性, 数据库管理系统, 质量控制

Abstract: The data coordination committee (DCC), an independent and third-party data management organization, can ensure the data quality of clinical trials to the greatest extent and make the data results more accurate, authentic, credible and reliable. This article focused on the establishment, operation and specific functions of the DCC from a large sample infertility clinical trial in the gynecological clinical base in the First Affiliated Hospital of Heilongjiang University of Chinese Medicine. DCC for data management in infertility clinical trials is not only professional, sustainable and consistent, but also can avoid the bias to the greatest extent, increase the transparency and credibility, and improve the efficiency of clinical trial management.

Key words: Clinical trials data monitoring committees, Clinical trial, Infertility, female, Database management systems, Quality control