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青少年艾滋病毒研究电子健康记录的监管问题:策略和经验教训
Sara Shaw Green1, Sung-Jae Lee2, Samantha Chahin1
1Center for Translational Behavioral Science, Department of Behavioral Sciences and Social Medicine, Florida State University, Tallahassee, FL, United States.
JMIR formative research
|May 2, 2024
概括
使用电子健康记录 (EHR) 实施多站点临床试验需要仔细规划. 解决监管挑战和建立数据使用协议对于成功,及时的HIV/AIDS干预研究至关重要.
科学领域:
- 临床试验 临床试验
- 医疗信息学 医疗信息学
- 公共卫生研究 公共卫生研究
背景情况:
- 电子健康记录 (EHR) 为临床试验研究提供了具有成本效益的基础.
- 在现实环境中使用EHR可以为新兴的成年艾滋病毒人群进行实用干预研究.
- 多站点EHR试验中的监管复杂性可能导致延迟和不合规.
研究的目的:
- 以突出监管过程和挑战,在实施一个多站点实用试验使用EHRs.
- 帮助未来的研究人员在类似研究中克服监管障碍.
- 确保遵守研究时间表和机构指导方针.
主要方法:
- 参与了八个站点,其中四个用于干预/数据提取,四个用于数据管理/分析.
- 建立了关于保留和病毒抑制的EHR数据收集的监管基础设施.
- 制定了机构依赖和数据使用协议,以及特定地点的培训.
主要成果:
- 一个分阶段的方法 (数据提取然后干预站点) 解决了独特的监管需求.
- 对于数据提取/干预站点来说,监管上网需要6个月.
- 对数据管理/分析站点的监管上网延长至10个月.
结论:
- 多站点EHR试验需要从提案阶段开始进行预先规划.
- 关键考虑因素包括培训,数据使用协议,依赖协议和IRB审查.
- 周密的规划确保了成功实施和遵守实用性的试验时间表.
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