数据协调委员会在不孕症临床研究不同阶段的作用和特点

数据协调委员会(Data Coordination Committee,DCC)是临床试验中一个独立第三方的数据管 理机构，是提髙临床试验数据质量,使数据结果更为准确、真实、可信的有效途径之一。文章以黑龙江中医药 大学附属第一医院妇科临床基地一项大型不孕症临床研究为例，对数据协调委员会的建立、人员组成、在不 孕症试验中的特色和优势及其具体职能进行描述；阐明了DCC在不孕症临床试验中的重要作用，能够最大程 度地避免临床试验过程中的偏倚，增加试验透明度和可信度，提髙临床试验管理效率。 ABSTRACT FROM AUTHOR]

Functions and Characteristics of Data Coordination Committee in Different Stages in A Large Sample Clinical Trial of Infertility

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.