1. Define the needs of the EU registries and databases on rare diseases
To define the state of the art of existing registries with reference to their legal basis; organizational and IT measures used; type of data collected; compliance with the rules on personal data protection; quality assurance; operational and financial support.
2. Identify key issues to prepare a legal basis
To assess the feasibility of an EU legal instrument to allow the integration of national information sources and the collation and exchange of data at the Community level in compliance with the EU Directive 45/96 and with other relevant provisions.
3. Agree on a Common data set and elaborate procedures for quality control
To define a minimum data set for all rare diseases; to define criteria for quality assessment of data, data sources and procedures in the registries.
4. Agree on the Register and Platform Scope, Governance and long-term sustainability
To define the scope, operation and governance model of the platform, balancing the interests of relevant stakeholders and ensuring long-term sustainability of the platform. To identify tools and other facilities to support the operation of platform users.
The project is organised in 8 Workpackages.