本文指出了队列研究在中医药临床研究中的应用与特点，重点阐述了中医药临床研究的质量控制与中医药队列研究的临床监查要点。队列研究比较适合于评价中医药的临床疗效，但队列研究不同于随机对照研究，其样本量较大，随访时间较长，对象容易失访，对临床监查带来新的挑战，尤其是多中心的前瞻性队列研究。

Cohort study is desirable for evaluating the clinical efficacy of traditional Chinese medicine(TCM). However, a cohort study needs a long duration and may easily lose contact with patients, as the result of a large sample size. In this context, a cohort study, a multicenter prospective cohort study in particular, has imposed the challenges on monitoring. This paper discusses cohort studies in the context of clinical TCM studies, and the main issues concerning the quality control and monitoring.

国家科技部“十一五”科技支撑计划（2006BAI11B01-03）：中医综合治疗方案提高结直肠癌术后根治率的国际多中心示范研究，负责人：杨宇飞。