The Regulatory team supports the activities performed by the investigators and researchers involved in the EPIICAL studies as well as the sponsor with reference to data protection, confidentiality and ethical and regulatory issues that may arise, ensuring that all project activities, including those related with clinical studies, are compliant with the applicable legal, ethical and regulatory provisions. (Read more)
In particular these aspects are addressed by the Regulatory team:
1) Data sharing across countries: Paediatric studies are usually multi-national and data are often shared among many excellence clinical centres that work together networking different countries. To allow safe and ethic data use, ad hoc data sharing agreements are implemented.
2) Data protection and confidentiality: To use the critical mass of information produced within EPIICAL, ad hoc procedures to ensure privacy and confidentiality of patients’ data exchanged among clinical centres are adopted. A special attention is dedicated to children’s right to privacy and confidentiality.
3) Ethical and regulatory requirements for conducting clinical studies: this issue has gained a great interest among the scientific and lay communities. Both in EU and worldwide the attention is focused on defining procedures for paediatric agreement and assent, paediatric risk-benefit and paediatric expertise in performing trials. All these aspects are implemented by EPIICAL.