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中国临床药理学与治疗学 ›› 2004, Vol. 9 ›› Issue (4): 474-476.

• 设计与统计 • 上一篇    下一篇

临床试验机构研究者培训的标准操作规程

王怡兵, 熊宁宁, 卜擎燕, 蒋萌, 刘芳, 邹建东, 符为民   

  1. 南京中医药大学附属医院国家药品临床研究基地, 南京210029, 江苏
  • 收稿日期:2003-12-03 修回日期:2004-01-17 出版日期:2004-04-26 发布日期:2020-11-20
  • 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:025-6506055 Fax:025-6555033 E-mail:jsszyyjd@jlonline.com, xiongnin@public1.ptt.js.cn
  • 作者简介:王怡兵, 女, 博士研究生。
  • 基金资助:
    科技部“ 临床试验关键技术及平台研究” 课题资助(№2002AA2Z341i)

Procedures for investigators training in institutions for clinical trials

WANG Yi-Bing, XIONG Ning-Ning, BO Qing-Yan, JIANG Meng, LIU Fang, ZHOU Jian-Dong, FU Wei-Min   

  1. National Base for Drug Clinical Trial, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Nanjing 210029, Jiangsu, China
  • Received:2003-12-03 Revised:2004-01-17 Online:2004-04-26 Published:2020-11-20

摘要: 合格的研究者是保证临床试验质量的关键。临床试验机构对研究者的培训, 是研究者获得参加其所承担试验项目资格的必备条件。本操作规程是依据GCP 以及我院对研究者培训的实践制订的。内容包括制定培训计划, 研究者的岗位培训, 临床试验项目开始前的研究者培训, 培训原则, 培训技巧,培训评估, 培训者资格审定, 以及文件和档案的建立等。

关键词: 临床试验机构, 研究者, 培训, 标准操作规程

Abstract: Qualified investigators play a key role in guaranteeing the quality of clinical trials.Receiving training programs arranged by clinical trial institution for each project is a prerequisite to qualify investigators.The SOP for training on the basis of GCP as well as practical experiences in this paper include establishing training plan, training programs for each position, pre-trail training programs, principles and techniques in training, evaluating training programs, reviewing qualifications of trainers, and maintaining training documentation and archives.

Key words: institution of clinical trial, investigator,training, standard operating procedures

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