访问爱尔兰母亲和新生儿临床管理系统的匿名数据,用于研究目的
Gillian M Maher1,2, Ali S Khashan1,2, Joye McKernan3
1INFANT Research Centre, University College Cork, Cork, T12YE02, Ireland.
HRB open research
|March 7, 2025
概括
访问匿名的母亲和新生儿临床管理系统 (MN-CMS) 数据进行研究需要一个多步骤的审批过程. 目前的系统访问这些宝贵的母亲和儿童健康数据可能需要6-12个月.
科学领域:
- 母婴健康信息学 母婴健康信息学
- 临床数据管理 临床数据管理
- 医疗保健服务研究 医疗服务研究
背景情况:
- 自2016年以来,爱尔兰的产科单位正在从纸质记录过渡到母亲和新生儿临床管理系统 (MN-CMS).
- 四家主要医院 (CUMH,UHK,Rotunda,NMH) 已经实施了MN-CMS.
- MN-CMS为母婴健康的数据驱动研究提供了巨大的潜力.
研究的目的:
- 概述要求访问匿名的MN-CMS数据进行研究的流程.
- 详细说明与数据访问请求相关的时间表.
主要方法:
- 要求从相关产科部门的临床领导开始.
- 详细的协议和数据收集表必须提交给国家信息治理小组批准.
- 每个单位的伦理委员会批准和数据保护影响评估是强制性的.
主要成果:
- 该过程涉及单独向每个产科单位的伦理委员会申请.
- 对于CUMH和UHK,需要向本地信息治理小组提交额外的申请,以获得后伦理审批.
- 数据提取和匿名化由该部门的数据管理人员执行,随后进行安全传输.
结论:
- 访问MN-CMS数据进行研究目前是一个复杂的,多阶段的程序.
- 需要一个标准化的国家流程来简化数据访问.
- 制定一个明确的途径将促进在母婴健康领域的关键数据驱动的发现.
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