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:
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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