Assent / Informed Consent Guidance for Paediatric Clinical Trials with Medicinal Products in Europe

On 25 January 2021 the European Network of Paediatric Research at the EMA’s (Enpr-EMA’s) Working Group on Ethics developed the guidance.

This document is intended to be used as an overview tool of the contents for assent/informed consent forms for all stakeholders (such as patients, sponsors and investigators) to support the conduct of high quality paediatric clinical trials in Europe across all paediatric age groups, from birth to less than 18 years of age.

Read the pdf 
Copyright Widler & Schiemann AG 2020. All Rights Reserved. /