Nagel Kim, Gender Jamie, Bonner Ann
Pediatric Hematology/Hemophilia/Thrombosis Department, McMaster Children's Hospital, Hamilton, Ontario, Canada.
Oncol Nurs Forum. 2010 May;37(3):E180-5. doi: 10.1188/10.ONF.E180-E185.
PURPOSE/OBJECTIVES: To describe the roles and responsibilities of the clinical research nurse (CRN).
A descriptive design was used to reveal the roles of pediatric oncology CRNs.
The Children's Oncology Group (COG) password protected Web site.
85 nurses who performed clinical research associate work within COG.
The Clinical Trials Nursing Questionnaire was used to investigate the roles and responsibilities of CRNs.
Protocol assessment, protocol planning, subject recruitment, informed consent process, investigational product, implementation and evaluation, data management, and professional nursing role.
The study found that 55% of respondents (n = 47) were employed in a hospital setting, the majority (81%) had more than five years of oncology experience, and the average age of respondents was 45.56 years (range = 24-65 years). CRNs rated all role components as very important, with the consent process being of greatest importance. Eighty-nine percent reported experiencing autonomy and independence in the role.
Clinical specialization of RNs has increased significantly in the past several decades. Acknowledging that nurses are responsible for performing many different roles that are critical to the successful completion of clinical trials is crucial.
Evaluation of this dual role is still in its infancy, but articulating the role of CRNs in the conduct and context of clinical research is an important first step.
目的/目标：描述临床研究护士（CRN）的角色和职责。
采用描述性设计以揭示儿科肿瘤学CRN的角色。
儿童肿瘤学组（COG）受密码保护的网站。
85名在COG内从事临床研究相关工作的护士。
使用《临床试验护理问卷》来调查CRN的角色和职责。
方案评估、方案规划、受试者招募、知情同意过程、研究产品、实施与评估、数据管理以及专业护理角色。
研究发现，55%的受访者（n = 47）受雇于医院环境，大多数（81%）有超过五年的肿瘤学经验，受访者的平均年龄为45.56岁（范围 = 24 - 65岁）。CRN将所有角色组成部分都评为非常重要，其中同意过程最为重要。89%的人报告在该角色中体验到自主性和独立性。
在过去几十年中，注册护士的临床专业化显著增加。认识到护士负责执行许多对临床试验成功完成至关重要的不同角色至关重要。
对这一双重角色的评估仍处于起步阶段，但阐明CRN在临床研究的开展及背景中的角色是重要的第一步。
