Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

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What does ICH E11 suggest regarding long-term surveillance of children in clinical trials?

It may be needed for monitoring safety during trials
It is not required
It may be needed to assess long-term cognitive effects
It may be needed to determine effects on development

The correct answer is: It may be needed to determine effects on development

The recommendation outlined in ICH E11 suggests that long-term surveillance of children in clinical trials may be necessary to understand the effects on development. This is critical because children are in a dynamic stage of growth and development, which can be influenced by exposure to medical interventions. Monitoring can provide insights into how such interventions affect various developmental milestones and health outcomes over time. Given that children are not just smaller versions of adults but have unique biological and psychological processes, elucidating the long-term impacts of clinical trials can help in ensuring safety and efficacy specifically tailored for pediatric populations. Understanding developmental effects is essential for establishing informed safety profiles and therapeutic guidelines that can support children's health as they grow.