改善电子资源网站的创业实践
Amy E Cramer1, Linda S King2, Michael T Buckley3
1Johnson & Johnson Innovative Medicine.
Research square
|June 3, 2024
概括
在临床试验中实施电子源 (eSource) 软件可以提高数据质量并降低成本. 关键的挑战包括识别冠军和商定方法,解决方案如FHIR标准的采用和共同的检查清单,以促进可扩展的eSource实施.
科学领域:
- 临床信息学 临床信息学
- 健康数据管理 管理健康数据
- 临床试验操作 临床试验操作
背景情况:
- 通过直接将电子健康记录数据复制到电子病例报告表格中,eSource软件可以提高临床试验中的数据质量和降低临床试验成本.
- 将eSource集成到多中心临床试验启动程序中,对于这些技术的更广泛采用至关重要.
研究的目的:
- 确定在多中心临床试验中启动eSource网站的关键步骤,挑战和解决方案.
- 分析已识别的挑战和解决方案对eSource实施团队的影响.
主要方法:
- 进行了定性整合性分析,以确定eSource网站的启动组件.
- 进行了价值分析,以根据其影响来优先考虑挑战和解决方案.
主要成果:
- 参与者确定了36个关键步骤,11个挑战和14个eSource网站启动的解决方案.
- 最主要的挑战包括缺乏网站 eSource 冠军和对 eSource 方法的分歧.
- 关键的解决方案包括供应商接受FHIR标准,标准化的法律文件,以及共同的准备清单.
结论:
- 在多中心临床试验中实施eSource在站点启动过程中提出了复杂的社会技术挑战.
- 已识别的解决方案为临床研究中可扩展的eSource采用提供了基础基础设施.
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