在学术临床试验单位服务基础设施的全球协调:一项国际调查
Jean-Marc Hoffmann1, Anette Blümle2, Regina Grossmann1
1Clinical Trials Center, University of Zurich and University Hospital Zurich, Zurich, Switzerland.
Frontiers in medicine
|October 30, 2023
概括
已建立的临床试验单位 (CTU) 将质量管理,监测和项目管理确定为基本服务. 新兴的CTU应该优先考虑这些核心功能和监管专业知识,以实现国际协调.
科学领域:
- 临床研究 临床研究
- 学术研究机构 学术研究机构
- 国际标准 国际标准 国际标准
背景情况:
- 世界各地的临床医生与苛刻的工作负载一起进行研究.
- 临床试验单位 (CTU) 对高质量的研究人员发起的试验 (IIT) 至关重要.
- 通过标准化实践和基础设施,CTU促进国际数据接受.
研究的目的:
- 根据国际标准,确定必要的服务,以便顺利处理临床试验.
- 为新兴的CTU提供一个资源,以建立他们的服务范围.
- 推动临床研究实践的国际协调.
主要方法:
- 根据AMEE指南,制定了一个问卷.
- 调查参与者是国际临床试验中心网络 (ICN) 内的已建立的CTU的高级代表.
- 调查问卷评估了各种CTU服务的感知重要性.
主要成果:
- 质量管理,监测和项目管理被认为是最重要的.
- 监管和法律事务,教育和培训以及数据管理也获得了很高的评分.
- 操作服务,如研究护士支持,被认为是最不重要的.
结论:
- 新兴的CTU应优先考虑质量管理,监管事务和培训服务.
- 专注于这些核心领域有助于满足临床研究的国际标准.
- 集团工业单位必须评估提供运营服务的资源可用性.
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