Module232025

12/05/2025

Site selection

• Personnel knowledgeable and skilled in dealing with the paediatric population and its age appropriate needs • Paediatric investigators, nurses and sites not adult centres • Child friendly • Convenient access • Consider funds for parent overnight accommodation + sibling facilities • Investigators who know the paediatricdisease with access to disease population • Study monitors experienced in paediatric studies • Plus all usual requirements and GCP

The Organisation for Professionals in Regulatory Affairs

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Conclusion

• Children are not small adults • Careful clinical trial design: essential for regulatory

approval and easy to conduct trials • Specialist consultation is essential

The Organisation for Professionals in Regulatory Affairs

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