WP3: Tools for neonatal & paediatric clinical trials

Objectives

To develop or adapt tools to be used for multinational paediatric clinical trials; this entails upgrading tools already developed by participants, especially ECRIN, taking into consideration paediatric specifications
To disseminate tools to PedCRIN and ECRIN partners
To train and support partners on the use of the tools

Survey targeting paediatric and neonatal users as well as patient communities to identify the needs of paediatricians in terms of infrastructures and tools for clinical trials.
Gap analysis to detect missing tools and services to support paediatric and neonatal trials
Upgrade, maintenance and sustainability of tools for paediatric trials (ethical and regulatory database, pharmacovigilance, etc.)
Upgrade, maintenance and sustainability of tools for neonatal trials
Dissemination of the tools to PedCRIN and ECRIN partners
Development of a procedure to enable access to individual patient clinical trial data