...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>BMC Medical Research Methodology >The role of the clinical research coordinator – data manager – in oncology clinical trials
【24h】

The role of the clinical research coordinator – data manager – in oncology clinical trials

机译：临床研究协调员（数据管理员）在肿瘤临床试验中的作用

获取原文
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Background The purpose of this study was to determine the standard tasks performed by clinical research coordinators (CRCs) in oncology clinical trials. Methods Forty-one CRCs were anonymously surveyed, using a four-page self-administered questionnaire focused on demographics, qualifications, and professional experience. The survey questions on responsibilities consisted of an ad-hoc 32-item questionnaire where respondents had to rate the frequency of involvement in the listed activities using a 3-point scale. We defined as "standard" a task that was rated as "in all or nearly all trials" by at least half of the respondents. Results A response rate of 90% (37 out of 41) was achieved after two mailings. Less than half of the respondents had received additional training in oncology, clinical research or Good Clinical Practices (GCP). Overall, all standard tasks performed by CRCs were in the category of "monitoring activities" (those usually performed by a Clinical Research Associate "CRA") and included patient registration/randomization, recruitment follow-up, case report form completion, collaboration with the CRA, serious adverse events reporting, handling of investigator files, and preparing the site for and/or attending audits. Conclusions CRCs play a key role in the implementation of oncology clinical trials, which goes far beyond mere data collection and/or administrative support, and directly contributes to the gathering of good quality data.
机译：背景技术这项研究的目的是确定临床研究协调员（CRC）在肿瘤学临床试验中执行的标准任务。方法采用四页自我管理的问卷调查问卷对41位CRC进行匿名调查，该问卷主要针对人口统计学，学历和专业经验。有关责任的调查问题包括一个临时的32项问卷，其中受访者必须使用3分制来对参与所列活动的频率进行评分。我们将至少一半的受访者认为“在所有或几乎所有试验中”的任务定义为“标准”。结果两封邮件后，答复率为90％（41个中的37个）。不到一半的受访者接受了肿瘤学，临床研究或良好临床实践（GCP）的额外培训。总体而言，CRC执行的所有标准任务都属于“监视活动”类别（通常由临床研究助理“ CRA”执行），包括患者注册/随机化，招募随访，病例报告表填写，与患者的协作。 CRA，严重不良事件报告，调查员文件处理以及为现场审核和/或参加审核做准备。结论CRC在肿瘤临床试验的实施中起着关键作用，这不仅限于数据收集和/或管理支持，还直接有助于收集高质量的数据。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号