Preparation of Informed consent and assent documents

This service supports the drafting of documents for the informed consent from parents/legally designated representatives and for the informed assent for children based on Regulation (EU) 536/2014, the EC Paediatric Ethical Recommendations (2017), GDPR and CIOMS/WHO Guidelines (2016). Separate documents will be prepared for participating in the clinical study, processing personal data and, where applicable, to handle genetic data.