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Enpr-EMA assent/ consent guidance

The Enpr-EMA working group on ethics has published “Assent/ informed consent guidance for paediatric clinical trials with medicinal products in Europe”. This document is intended to be used as a tool for all stakeholders (such as patients, sponsors and investigators) which provides practical recommendations for the contents for assent/ informed consent forms to support the conduct of paediatric clinical trials in Europe.

It is published on the EMA website >>> | Direct link to document >>>

 

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