Module232025

12/05/2025

Timing of trials: Age selection

Main development

Main or Paediatric study

Adult

Paediatric study

Adolescent

Younger Children

The Organisation for Professionals in Regulatory Affairs

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Protocol: Adverse event reporting

• AEs that are tolerable for adults may not be tolerable for children • AE spectrum may be different to that seen in adult studies • Avoid double reporting of AEs (parent and child) • Ensure adequate training of site personnel in asking safety questions • Will likely require use of an independent Data Monitoring Committee with appropriate membership skilled in paediatric studies

The Organisation for Professionals in Regulatory Affairs

26