[Quality control and measures of China National Birth Cohort].

Birth cohort is an effective method to explore the relationship between various prepregnant and pregnant exposures and the health of fetuses, infants and young children. It is a long construction period to build a birth cohort and the quality of research may be affected by many factors. This paper reviews the quality assurance and quality control measures in the process of China National Birth Cohort (CNBC), and summarizes the construction experience. We aim to provide experience for related cohort studies, which could improve the quality of cohort studies through removing the impact of related factors. CNBC adopted a series of measures to ensure the quality of research in the top-level design of quality assurance, including screening research center, developing member management system, formulating standard operating procedures and training staff by it. In terms of quality control, it includes real-time, timely and timing quality control for the process of data generation, full-cycle quality control for biological sample collection, processing, storage and comprehensive three-dimensional quality control for staff training, supervision and quantitative assessment. 出生队列是研究孕前和孕期各种环境暴露因素与胎儿、婴幼儿、青少年健康之间关系的有效方法。出生队列建设周期长、环节众多，研究质量可能受到多种因素的影响。本文对中国国家出生队列建设过程中的各项质量保证和质量控制措施进行梳理，归纳总结建设经验。以期为相关队列研究提供经验，减少相关因素对队列研究的影响，提升队列研究质量。中国国家出生队列在质量保证的顶层设计方面采取一系列措施保障研究质量，包括研究中心筛选、成员管理系统开发、标准化操作流程制定及工作人员规范化培训；在质量控制方面，包括针对队列数据产生过程的实时、及时、定时质控，针对生物样本采集、处理及保存的全周期质控，以及针对参与工作人员的培训、督查和量化考核的全面立体质控。.