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Informed consent design and writing for pediatric study

A large pharma company requested us to design and write a child friendly informed consent form for a pediatric clinical study.

The challenge was to provide enough information in an understandible language for children from different age groups and their parents.

Our approach

The aim of the clinical study was to recruit patients under the age of 18 years. Therefore different Informed Consent Forms needed to be developed for the children and the parents.

The following ICF templates were designed:

  • For children from 7 to 11 years
  • For children from 12 to 17 years
  • For children who become adults (>= 18 year) during the study
  • For parents of the children
  • Pregnancy follow-up template for adults  (>= 18 year) during the study
  • Pregnancy follow-up template for parents (of children)

Because the study protocol was set-up in two different parts, ICF templates needed to be created for both part 1 and part 2 of the study. This resulted in a total of 12 informed consent templates that needed to be created.


An introduction meeting at Sponsor's office took place to discuss the approach for the design and writing of the Informed Consent Forms.

Continuous collaboration between Pivotal's team and the Sponsor's team (project manager & medical advisors) was crucial to foresee a delivery of the templates within the timelines.


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