Question:
在ICH GCP E6 R2中的5.0.2 Risk Identification The sponsor should identify risks to critical trial processes and data. Risks should be considered at both the system level (e.g., standard operating procedures, computerized systems, personnel) and clinical trial level (e.g., trial design, data collection, informed consent process).请问如何理解的personnel在 system level呢?有什么例子可以分享吗?谢谢!
Answer:
指人员配置和能力管理体系,比如人员的资质、培训、工作量及流动情况等等。