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中国临床药理学与治疗学 ›› 2006, Vol. 11 ›› Issue (10): 1190-1193.

• 设计·统计·方 • 上一篇    下一篇

临床试验的重要角色:临床研究协调员

卜擎燕1,2, 熊宁宁2, 邹建东2, 蒋萌2, 刘芳2, 汪秀琴2, 高维敏2   

  1. 1南京中医药大学;
    2南京中医药大学附属医院临床药理科, 南京 210029, 江苏
  • 收稿日期:2006-04-14 修回日期:2006-07-12 出版日期:2006-10-26 发布日期:2020-11-05
  • 通讯作者: 熊宁宁,男, 教授, 主任医师, 博士生导师, 主要从事临床药理研究。Tel:025-86506055 E-mail:jsszyyjd@jlonline.com
  • 作者简介:卜擎燕, 女, 博士研究生, 从事临床试验数据管理研究。Tel:025-86555033  E-mail:janepqy@126.com
  • 基金资助:
    国家科学技术部“临床试验关键技术及平台研究”课题资助(No2004AA2Z3766)

Key role in clinical trial:clinical research coordinator

BO Qing-yan1,2, XIONG Ning-ning2, ZOU Jian-dong2, JIANG Meng2, LIU Fang2, WANG Xiu-qin2, GAO Wei-min2   

  1. 1Nanjing University of TCM, Nanjing 210029 , J iangsu, China;
    2Department of Clinical Pharmacology , Affiliated Hospital of Nanjing University of TCM, Nanjing 210029 , Jiangsu, China
  • Received:2006-04-14 Revised:2006-07-12 Online:2006-10-26 Published:2020-11-05

摘要: 临床研究协调员(CRC) 在国外作为临床试验中的一员和一项专门的职业已有30 多年历史。CRC 主要由护理、药剂等生物医学专业背景的人员担任。CRC 的工作范围涉及到临床试验的各个方面, 包括试验的准备, 与伦理委员会和申办者的联络, 协助试验实施的各项工作, 如获取知情同意, 与患者及其家属的教育、联络、咨询与商谈, 数据收集与CRF 转录, 以及临床检查、不良事件、试验药物、文件资料等管理, 应对监查、稽查与视察。CRC 对确保临床试验的伦理合理性、科学性及试验数据的可信度方面起重要保证作用。

关键词: 临床研究协调员, 研究护士, 研究协调员, 机构协调员, 临床试验

Abstract: Clinical research coordinator (CRC) has been an important role in clinical trial and as a profession for almost 30 years in foreign countries.Most CRCs have professional backgrounds of nurse, pharmaceuticals and other biomedical specialties.CRC's scope of work involves each aspects of clinical trial, including preparation of clinical trial, liaison with IRB and sponsor, and assisting in the operation of trials, such as obtaining informed consent, diseases management education, liaison, consultation and discussion with patients and their families,data collection and CRF transcription, management of clinical examination, adverse event, trial medicine, clinical trial files and other materials, as well as responding to monitor and audit and inspection.CRC plays an important role in guaranteeing the ethic and scientific rationality,and the reliability of data in clinical trial.

Key words: clinical research coordinator, study nurse research nurse, study coordinator site coordinator, clinical trial

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