药物临床试验专职研究护士模式的实施与探讨

Implementation and discussion of full-time research nurse mode in drug clinical trials

研究护士在临床研究团队中起着不可或缺的中心作用与协调作用,是临床试验成败的关键因素之一。我国临床研究护士在药物临床试验中存在身兼数职、培训制度不健全及配套保障机制不完善等问题。本院通过建立专职研究护士系统的遴选方式、专业培训体系、经费分配制度、评奖评优考核机制,实施临床试验与职称考核挂钩机制,客观衡量专职研究护士在临床试验中的劳动贡献,使专职研究护士的培训、使用、管理逐步走上科学化、规范化道路。

Research nurses play an indispensable central and coordinating role in the clinical research team,and are one of the key factors for the success or failure of clinical trials.In our country,there are many problems in clinical research nurses of drug clinical trials,such as holding several posts concurrently,incomplete training system and imperfect supporting guarantee mechanism.Our hospital has established a full-time research nurse system selection method,professional training system,economic fee distribution system,and awards evaluation and assessment,and implemented a mechanism for linking clinical trials and professional title evaluation to objectively measure the labor contribution of full-time research nurses in clinical trials,so that the training,use,and management of full-time research nurses gradually embarked on a scientific and standardized path.